HeartSine Technologies, Ltd. 207 Airport Road West Belfast Northern Ireland BT3 9ED United Kingdom Tel: +44 28 9093 9400 Fax: +44 28 9093 9401 Stryker is conducting a voluntary recall as we have determined that the affected Pad-Paks may be rendered inoperable due to depleted battery cells. the PAD 300/PAD 300P is operable and in ready standby mode as indicated by a flashing green LED (see the HeartSine Samaritan PAD SAM 300/300P User Manuals). OUS: Australia, Czechia, Canada, New Zealand. We are committed to supporting your HeartSine SAM 300/300P within the device warranty period. The device history records for the returned sam 300p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the despatch of the sam 300p from heartsine technologies, belfast on the (b)(6) 2009. FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs. *, *https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds. . Language Check: Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable). *https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds. Adult (includes one set of adult defibrillation pads and battery). PDF HeartSine samaritan PAD 300P Upgrader (1.4.2/3.2.0) - Amazon Web Services Thank you for your business and continued partnership. A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. HeartSine samaritan AED was discontinued in 2006 and accessories have not been marketed since 2013. All other trademarks are trademarks of their respective owners or holder. FDA MedWatch - HeartSine Samaritan Public Access Defibrillator 300/300P HeartSine PAD 300/PAD 300P public access defibrillators (semi-automated) The FDA announced a Samaritan PAD 300/300P recall on November 19, giving it a class 1 designation; the most serious recall classification. Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. 300 or SAM 300P and the Pediatric -Pak will not be available for use with SAM 300P after . FDA Class I Recall For HeartSine Samaritan Public Access Defibrillator PDF HeartSine samaritan PAD 300P - Amazon Web Services Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. HeartSine PMA-approved SAM 350P, SAM 360P, and SAM 450P devices. Stryker's planned discontinuations (October 2020) %%EOF 4) Press On/Off button to turn off the device. Uses 2 "AAA" batteries (not included). 465 0 obj <>/Filter/FlateDecode/ID[<82025359F35FF84CAE1E3B47481D4A24>]/Index[441 38]/Info 440 0 R/Length 115/Prev 471498/Root 442 0 R/Size 479/Type/XRef/W[1 3 1]>>stream February 3,2022. Attach PAD 300P to computer's USB port (see User Manual). SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080. (PDF, combined English, Deutsch,Espaol,Franais,Italiano), HeartSine samaritan PAD 300P Upgrader(1.4.2/3.2.0). Heartsine Samaritan Pediatric AED Pads & Battery- Pad-Pak. Power Problems Lead to Heartsine Defibrillator Recall hVYoF+p>$j L7 bXL >3Ky jcc` LX2f=3^`aL b:j&- >Li"{ ?\2cDg,':V,CYJ}'9XmK>=X?$PK~)cwm7oe2)bOYK*H{nuN#B[j(JNz We are committed to providing high-quality, clinically relevant products so that you can be confident in the care you are providing to your communities. . Heartsine Samaritain 300p Aed W/extra Pak Pad Retails For Over $1650.00 HeartSine Technologies, Ltd. 207 Airport Road West Belfast Northern Ireland BT3 9ED United Kingdom Tel: +44 28 9093 9400 Fax: +44 28 9093 9401. The yellow and black color scheme is a registered trademark of Stryker Corporation. MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE If you have questions or concerns contact Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at heartsinesupport@stryker.com. The FDA has issued a Class I recall, it's highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator (PAD) which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose. The yellow and black color scheme is a registered trademark of Stryker Corporation. US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR FDA | Automated External Defibrillator (AEDs) website HeartSine customer letter HeartSine FAQs. Please wait while you are redirected to the right page Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: HeartSine, samaritan, CPR Advisor, CPR Rate Advisor, HeartSine Gateway, HeartSine vTrainer, LIFELINKcentral, Saver EVO, SCOPE. PDF AED product discontinuation FAQs - Amazon Web Services Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness. You have been directed to this webpage to enable you to upgrade your PAD 300/300P device in accordance with HeartSine Technologies' field safety corrective action dated 11 September 2012. Please wait while you are redirected to the right page Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: HeartSine, samaritan, CPR Advisor, CPR Rate Advisor, HeartSine Gateway, HeartSine vTrainer, LIFELINKcentral, Saver EVO, SCOPE. For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following. Pad-Pak and Pediatric-Pak are not PMA approved for use with SAM 300 or SAM 300P. Heartsine Samaritan PAD SAM 300P Defibrillator AED - eBay The recalling firm will provide a replacement device. Recall Date: 09/12/2012 Title: HeartSine Samaritan 300/300P PAD Voluntary Recall Units: HeartSine Samaritan 300/300P PADs, if your unit was recalled you will have received a letter directly from HeartSine. FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs. *. HeartSine - English 1) Confirm that the device has incorrect language voice prompts by using the Device Language Check. 478 0 obj <>stream Customers were instructed to return affected product to there distributors. If 300/300P the deviceturnsto itself on and off OR if your an area where device displays a Low Battery Warning before the expiry date labelledthe audible on the PAD-PAK in the device,contact HeartSine Technologies, at 1-877-877-0147 immediatelyso that 3.Immediately increase Sudden Cardiac Arrest (SCA) strikes without warning. FDA | Automated External Defibrillator (AEDs) Website, HeartSine customer letter HeartSine FAQs. In addition, HeartSine is providing a software upgrade to bring all users up to a more recent version of the software. hbbd```b``M i1dO ``N0^`fiwH2:Q`6TU9G?WL`YF_ \ You will be receiving and email with a link to the PDF. Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913), Diabetic Ketoacidosis (2364); No Patient Involvement (2645), Instructions for Downloading Viewers and Players. Heartsine Samaritan PAD AED Pads and Batteries - AEDUniverse.com I purchased this new myself for my office as required by law to perform office procedures, and it stayed in its included wall case for its entire life. 3) Press the On/Off button. We are committed to providing high-quality, clinically relevant products so that you can be confident in the care you are providing to your communities. H023-001-009-8 Previous Page Next Page 1 2 3 4 5 HeartSine announced the End of Life and End of Trading of the HeartSine samaritan PAD 300/300P (SAM 300/300P) Automated External Defibrillators (AEDs) in July 2016. For question contact Quality Manager at +44 (0)28 90 93 94 19. HeartSine samaritan PAD 300P Upgrader (1.4.2/3.2.0) The Upgrade requires a HeartSine data cable. The yellow and black color scheme is a registered trademark of Stryker Corporation. Worldwide Distribution and US (nationwide) in the following states: AK, AL, AP, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, WA, and WI. More Find Heartsine Samaritain 300P AED W/extra PAK PAD Retails for over $1650.00 in Fort Worth, Texas, United States, for US $800.00. If you have any questions or concerns, please contact HeartSine Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at RSRecall@stryker.com. 3. The letter identifed the affected product, problem and actions to be taken. Product notices - HeartSine - United Kingdom Note: If a Software Installation warning window is displayed when you attempt to download the Upgrader software, select the Continue Anyway option. YSt!i[[L->1]$j%emeFFqz^V\z[yl}@g?+:k1k62~%)k# Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: HeartSine, samaritan, CPR Advisor, CPR Rate Advisor, HeartSine Gateway, HeartSine vTrainer, LIFELINKcentral, Saver EVO, SCOPE. PAD-PAK-01 Heartsine Samaritan Adult Set - AED Brands BELFAST, United Kingdom---- On September 13, 2012, HeartSine Technologies, Ltd. initiated a voluntary global correction of certain Samaritan 300/ 300 P PAD public access defibrillators to . Please check your spam folder and add info@marketing.think-safe.com to your address book so you dont miss out on important information from Think Safe. samaritan PAD 300P . AUDIENCE: Consumer. HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR: Back to Search Results: Model Number PAD: Device Problem . Therefore, while Pad-Pak and Pediatric-Pak will continue to be available for use with SAM 350P, SAM 360P, and SAM 450P devices, Pad-Pak will not be available for use with SAM 300 or SAM 300P and Pediatric-Pak will not be available for use with SAM 300P after. O desempenho do Algoritmo de Anlise de Arritmia de ECG do SAM 300P da HeartSine est resumido na tabela abaixo: Classe de Ritmo This website uses cookies to ensure you get the best experience on our website. 2023 HeartSine Technologies, Ltd. All Rights Reserved. FDA News FDA MedWatch - HeartSine Technologies Samaritan 300/300P PAD FDA event timeline Class 1 Recall: HeartSine Samaritan Public Access Defibrillator 300/300P A seconde letter, dated June 30th, was sent to end users to clarify where on the label to find lot specific information. Emergency Management Mobile Application. The website cannot function properly without these cookies. Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. HeartSine / Samaritan 300/300P PAD Voluntary Recall Experience has shown that it is reasonable to conclude that these symptoms may be attributed to membrane failure, the pad-pak, which contains the electrodes and batteries, is labelled for single use but the samaritan pad 300 and 300p devices are for multi-use, which is why the "unknown" box has been checked in section of this report. Stryker has announced discontinued support for the HeartSine samaritan AED, HeartSine samaritan PAD 300 and 300P (SAM 300, SAM 300P) legacy public access defibrillators in the United States. HeartSine Samaritan (R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106. Devices which are no longer within their warranty period will not be eligible for support, repair or replacement. See Terms of Use & Privacy Policy. hb```a``c`e`Igb@ !+sLhtM*y,ewLKj &p^gi@1VAde ZM&. 2023 HeartSine Technologies, Ltd. All Rights Reserved. HEARTSINE SAM300P USER INSTRUCTIONS Pdf Download | ManualsLib September 2019 In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later thanFebruary 3, 2021. This device was returned to heartsine technologies as part of the current fsca/recall, fda reference z-0124-2013. Product discontinuations Stryker has announced discontinued support for HeartSine samaritan AED, HeartSine samaritan PAD 300 and 300P (SAM 300, SAM 300P) "legacy" public access defibrillators in the United States. On Nov. 19, the U.S. Food and Drug Administration (FDA) issued a Class I recall for certain HeartSine Samaritan 300/300P PAD devices. HeartSine samaritan PAD 300P Upgrader (1.4.2/3.2.0) Confirm that the LED light is flashing green. See Terms of Use & Privacy Policy. 4) Complete and return the acknowledgement form to heartsinesupport@stryker.com HeartSine Technologies, Ltd. 207 Airport Road West Belfast Northern Ireland BT3 9ED United Kingdom Tel: +44 28 9093 9400 Fax: +44 28 9093 9401. Recall: HeartSine Samaritan Defibrillator September 18, 2013 by nwrnbulletins The FDA has announced a recall of the HeartSine Technologies Samaritan 300/300P public access defibrillator because of power problems. A Especificao e Sensibilidade do Algoritmo de Anlise de Arritimia de ECG do SAM 300P da HeartSine est de acordo com as exigncias da AAMI DF80a de 2003 e com as diretrizes da AHA. MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES, LTD HEARTSINE We are pleased to have PMA approval for the HeartSine samaritan PAD family of automated external defibrillators, including SAM 350P, SAM 360P, and SAM 450P. Device observed switching on automatically. FDA Issues Class I Recall for Certain HeartSine Public Access - JEMS Note: If a Software Installation warning window is displayed when you attempt to download the Upgrader software, select the "Continue Anyway" option. Friday or by email at RSRecall@stryker.com. See Terms of Use & Privacy Policy. 441 0 obj <> endobj PDF Heartsine Samaritan 300P - HPRA samaritan PAD 300P . For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following. The recall was to address two issues: Some HeartSine PAD 300/PAD 300P devices intermittently turn on and off while on standby, draining the battery over time and potentially preventing use when needed during a cardiac event. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language. 2) If the device is found to have incorrect language configuration, remove it form use. !c^)oEepO0eS)u;.Hy|4V\>#:*O6:=dX8bW4V-rgFre0kS^|YA&}y;MO"J?uQoC!2^BmH0{0$,Am93h We have received your form request. All other trademarks are trademarks of their respective owners or holder. We paid over $1200 as I recall. 2. HeartSine Technologies, Ltd. Issues Global Correction of - CNBC I'm an OB/GYN physician. The Heartsine samaritan AED PAD-PAK . You can close this box and continue browsing our website. Certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, Thu Sep 13 2012 By Other Author HeartSine Samaritan Public Access Defibrillator 300/300P: Class I Recall - Device May Intermittently Turn On and Off. Recall Status 1: Terminated 3 on April 16, 2015: Recall Number: Z-2115-2014: Recall Event ID: 68703: 510(K)Number: K052465 K123881 Product Classification: Automated external defibrillators (non-wearable) - Product Code MKJ: Product: Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). September 2019 In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later than February 3, 2021. 300P - HeartSine - United Kingdom When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit. PAD SAM300P USERS MANUAL ABOUT THIS EDITION The information in this manual applies to the HeartSine Technologies samaritan PAD sam300P automatic external defibrillator. Recalls | PMA | HDE | Classification | Standards: CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC : HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR: Back to Search Results: Model Number SAM: Device Problems Self-Activation or Keying (1557); Device . There have been no reports of adverse events or cases of patient involvement to date. Note: If a Software Installation warning window is displayed when you attempt to download the Upgrader software, select the "Continue Anyway" option. October 2020 Due to hardship related to the COVID-19 pandemic the FDA updated their website with a deadline extension for marketing AED accessories to no later thanFebruary 3, 2022. Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, REF/UDI-DI/Serial Numbers: Distributors were given a letter to use in communications with customers on June 17, 2014. PAD-PAK-01. For questions call 1-877-877-0147 or your service representative.The company issued an Device Recall PadPak and PediPak accessories for the HeartSine SamaritanPAD 300P and 350P device Model / Serial Pad-Pak 01 & Pad-Pak 02 Adult Lot Numbers: A1785 to A1805 Pediatric Lot Numbers: P433 to P445. Background. 510(K)s with Product Code = MKJ and Original Applicant = HEARTSINE TECHNOLOGIES, INC. If the LED is red or unlit, contact HeartSine Technologies, at +800 1212 5555 immediately so that we may send you a replacement unit. See Terms of Use & Privacy Policy. No patient was involved in this event. 5. The device detailed in this report was returned to heartsine technologies as part of the fsca/recall z-0124-2013 with no allegation of any fault with the device. endstream endobj startxref ZI2Gu[S:V%S{yrF5/ ^mf[^w4]Ww+V2c,?J)lWMco~E DO NOT If necessary, be device(s) Samaritan initiated. Heartsine samaritan PAD Trainer Replacement Remote Control. Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. PDF SAM300P USERS MANUAL - HeartSine 2) Verify the green status indicator is blinking. Also, all major AED manufacturers and their models have had software or hardware upgrades through FDA field corrective actions or FDA equipment recall notices. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: HeartSine, samaritan, CPR Advisor, CPR Rate Advisor . Class 2 Device Recall PadPak and PediPak accessories for the HeartSine Class 1 Recall: HeartSine Samaritan Public Access Defibrillator 300/300P The firm issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. Start PAD 300P Upgrader. The yellow and black color scheme is a registered trademark of Stryker Corporation. H017-019-134- UL 300P Indonesian User Manual. List Price: $269.85. Heartsine technologies ltd is submitting the report on (b)(4). 1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a "double click". https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds. Incorporates one expiration date for worry-free maintenance. 300P - HeartSine . Recall: HeartSine Samaritan Defibrillator | esrdbulletins Product discontinuation notice for HeartSine samaritan PAD 300/300P. %PDF-1.6 % had not yet responded to the companys efforts. endstream endobj 442 0 obj <>/Metadata 60 0 R/Outlines 106 0 R/Pages 439 0 R/StructTreeRoot 115 0 R/Type/Catalog>> endobj 443 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 444 0 obj <>stream Statistic cookies help website owners to understand how visitors interact with websites by collecting and reporting Heartsine Samaritan PAD SAM 300P Defibrillator AED. Heartsine technologies ltd (manufacturer) is submitting the report on behalf of heartsine technologies llc (importer). October is National Sudden Cardiac Awareness Month, Advanced Life Support (ALS) Equipment & Accessories, Automated External Defibrillators (AEDs), Accessories & Packages, CPR Technology & Emergency Oxygen Equipment, Personal Protective Equipment, BBP & Sharps, Responder, Trauma, Active Violence & Severe Bleed Kits, Self-contained Emergency Treatment (SET) System, Emergency Alerting & Communication Software, First Voice Medical Direction / Oversight, CUSTOMIZED & WHITE LABEL SOFTWARE SOLUTIONS, EMERGENCY MANAGEMENT MOBILE APPLICATION (EMMA), OSHA BEST PRACTICE CPR, AED, FIRST AID PROGRAMS, 48 Packs of Germisept Multi-Purpose Wipes, 50-Pack PPE Kit w/ Purchase of Two (2) AEDs, First Voice Training for 30 w/ Train-the-Trainer with Purchase of Three (3) AEDs, 1-Year Subscription to E.M.M.A (Emergency Management Mobile Application) w/ Purchase of Two (2) AEDs, 1-Year of First Voice Manager Compliance Software, 2-Years of Remote Monitoring Cellular Service, HeartSine Samaritan AED Defibrillator with Purchase of 3,000 Packs, 50-Pack PPE Kit with Purchase of 2,016 Packs, First Voice Training for 30 w/ Train-the-Trainer with Purchase of 1,104 Packs, 1-Year Subscription to E.M.M.A. Cookie purpose description: Used by the content network, Cloudflare, to identify trusted web traffic. Can only be used with TRN-300-US-05 Trainer. ISSUE: Certain Samaritan 300/300P PAD devices manufactured before December 2010 have been found to intermittently turn on and off, which may eventually deplete the battery.In addition and separately, certain Samaritan 300/300P PAD devices containing early versions of . ISSUE: HeartSine notified customers that certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, which may eventually deplete the battery.In addition and separately, certain Samaritan 300/300P PAD . HeartSine samaritan PAD 300P Upgrader User Instructions Dont let your AED become out of date from American Heart Association (AHA) guidelines. HeartSine notified distributors in the United States by e-mail on June 12, 2014 and by follow-up letter on June 13, 2014. additional press release on September 13, 2013 in a further attempt to reach out to end customers that SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; oUp- Pad-Pak 01 & Pad-Pak 02 Adult Lot Numbers: A1785 to A1805 Pediatric Lot Numbers: P433 to P445. PDF URGENT: MEDICAL DEVICE RECALL -- Samaritan 300/300P PAD Instructions for Downloading Viewers and Players. (Emergency Management Mobile Application) w/ Purchase of 1,104 Packs, 1-Year of First Voice Manager Compliance Software with Purchase of 1,104 Packs, 1-Year Medical Direction / Physicians Oversight with Purchase of 2,016 Packs, 2 -Years of Remote Monitoring Cellular Service with Purchase of 1,800 Packs, HeartSine Samaritan AED Defibrillator with Purchase of 4 PPE Bundles, 48 Packs of GERMisept Multi-Purpose Wipes, First Voice Training for 30 w/ Train-the-Trainer with Purchase of 2 PPE Bundles, 1-Year Subscription to E.M.M.A.
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