Our Price: $228.00. April 2019 The FDA communicated with all AED manufacturers regarding the final order requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories by February 3, 2020: In April 2019, the FDA sent letters to all AED manufacturers, who did not submit a premarket approval (PMA) application for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed. *. All other trademarks are trademarks of their respective owners or holder. Device observed switching on automatically. 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. Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. Heartsine technologies ltd is submitting the report on (b)(4). All other trademarks are trademarks of their respective owners or holder. hbbd```b``M i1dO ``N0^`fiwH2:Q`6TU9G?WL`YF_ \ FDA event timeline Uses 2 "AAA" batteries (not included). 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 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. For question contact Quality Manager at +44 (0)28 90 93 94 19. samaritan PAD 300P . Find Heartsine Samaritain 300P AED W/extra PAK PAD Retails for over $1650.00 in Fort Worth, Texas, United States, for US $800.00. 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. Incorporates one expiration date for worry free maintenance. 1) Confirm that the device has incorrect language voice prompts by using the Device Language Check. Pad-Pak and Pediatric-Pak are not PMA approved for use with SAM 300 or SAM 300P. See Terms of Use & Privacy Policy. 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. The yellow and black color scheme is a registered trademark of Stryker Corporation. While the Pad-Pak and Pediatric-Pak will continue to be available for use with the SAM 350P, SAM 360P, and SAM 450P devices, the Pad-Pak and Pediatric-Pak are not PMA approved for use with the SAM 300 or SAM 300P; therefore the Pad-Pak will not be available for use with the SAM 300 or SAM 300P and the Pediatric-Pak will not be available for use with SAM 300P after February 3, 2021. 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. February 3,2022. On 2/1/23, correction notices were mailed to customers who were asked to do the following: Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their . 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. This one has the kit that comes with original Pad Pak that expires May 2016 and comes with another one that . Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable), Code of Federal Regulations (CFR) Title 21 7.55. Cookie purpose description: Used by the content network, Cloudflare, to identify trusted web traffic. SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; 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 . The Heartsine samaritan AED PAD-PAK . HeartSine samaritan PAD 300P Upgrader User Instructions. The Upgrade requires a HeartSine data cable. 2023 HeartSine Technologies, Ltd. All Rights Reserved. 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. HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR: Back to Search Results: Model Number PAD: Device Problem . Product discontinuation notice for HeartSine samaritan PAD 300/300P. Confirm that the LED light is flashing green. 2) Verify the green status indicator is blinking. Incorporates one expiration date for worry-free maintenance. As a result, the affected Pad-Paks could potentially fail to power on the device if needed for use. Shipped FedEx with tracking from Texas. 300 or SAM 300P and the Pediatric -Pak will not be available for use with SAM 300P after . We are committed to supporting your HeartSine SAM 300/300P within the device warranty period. Start PAD 300P Upgrader. SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; HeartSine samaritan AED was discontinued in 2006 and accessories have not been marketed since 2013. 2023 HeartSine Technologies, Ltd. All Rights Reserved. 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. *. 4. Heartsine Samaritan Pediatric AED Pads & Battery- Pad-Pak. Note: If you need help accessing information in different file formats, see Worldwide Distribution - US (nationwide) and in Canada, Mexico and Latin America. On Nov. 19, the U.S. Food and Drug Administration (FDA) issued a Class I recall for certain HeartSine Samaritan 300/300P PAD devices. I have not delved into this however. endstream endobj startxref If your buying these units there are certain serial numbers that have recalls so be careful. AUDIENCE: Risk Manager, Health Professional. Necessary cookies help make a website usable by enabling basic functions like page navigation and access to secure areas of the website. Devices which are no longer within their warranty period will not be eligible for support, repair or replacement. US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR 5. 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. A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. 2) If the device is found to have incorrect language configuration, remove it form use. The data obtained from the device showed evidence that the device was switching itself on automatically for 10 minute durations between (b)(6) 2017. (Emergency Management Mobile Application) w/ Purchase of 8 PPE Bundles, 1-Year of First Voice Manager Compliance Software with Purchase of 2 PPE Bundles, 1-Year Medical Direction / Physicians Oversight with Purchase of 4 PPE Bundles, 2-Years of Remote Monitoring Cellular Service with Purchase of 2 PPE Bundles, 2 Training Packs = free Medical Direction, E.M.M.A. The yellow and black color scheme is a registered trademark of Stryker Corporation. https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds, FDA | Automated External Defibrillator (AEDs) website. List Price: $269.85. Stryker's planned discontinuations (October 2020). Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). 2023 HeartSine Technologies, Ltd. All Rights Reserved. Starten Sie nach dem Download die Datei PAD300PUpgrader_setup.exe", um 2. Adult (includes one set of adult defibrillation pads and battery). The FDA requires AED manufacturers to ensure customers who previously purchased the HeartSine samaritan AED, SAM 300, or SAM 300P are aware of the PMA requirement and the need to transition to a PMA-approved AED in a timely manner. Stryker is conducting a voluntary recall as we have determined that the affected Pad-Paks may be rendered inoperable due to depleted battery cells. If the LED is red or unlit, contact HeartSine Technologies, at +800 1212 5555 immediately so that we may send you a replacement unit. Note: If a Software Installation warning window is displayed when you attempt to download the Upgrader software, select the "Continue Anyway" option. AUDIENCE: Consumer. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language. Provides over 6 hours of continuous monitoring or 60 shocks. H017-019-134- UL 300P Indonesian User Manual. hVYoF+p>$j L7 bXL >3Ky jcc` LX2f=3^`aL b:j&- >Li"{ ?\2cDg,':V,CYJ}'9XmK>=X?$PK~)cwm7oe2)bOYK*H{nuN#B[j(JNz 2023 HeartSine Technologies, Ltd. All Rights Reserved. You will be receiving and email with a link to the PDF. 441 0 obj <> endobj additional press release on September 13, 2013 in a further attempt to reach out to end customers that Also, all major AED manufacturers and their models have had software or hardware upgrades through FDA field corrective actions or FDA equipment recall notices. Instructions for Downloading Viewers and Players. Attach PAD 300P to computer's USB port (see User Manual). Sudden Cardiac Arrest (SCA) strikes without warning. Distributors were asked to return the affected product to HeartSine. 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. HeartSine PMA-approved SAM 350P, SAM 360P, and SAM 450P devices. The FDA announced a Samaritan PAD 300/300P recall on November 19, giving it a class 1 designation; the most serious recall classification. PMAs with Product Code = MKJ and Original Applicant = HeartSine Technologies, Ltd. (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. 3) Press the On/Off button. 0 Note: If you need help accessing information in different file formats, see For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following. !c^)oEepO0eS)u;.Hy|4V\>#:*O6:=dX8bW4V-rgFre0kS^|YA&}y;MO"J?uQoC!2^BmH0{0$,Am93h The FDA requires AED manufacturers to ensure customers who previously purchased the HeartSine samaritan AED, SAM 300, and SAM 300P are aware of the PMA requirement and the need to transition to a PMA-approved AED in a ti mely manner. Emergency Management Mobile Application. Adult (includes one set of defibrillation pads and battery). Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Code of Federal Regulations (CFR) Title 21 7.55. 2023 HeartSine Technologies, Ltd. All Rights Reserved. Certain Samaritan 300/300P PAD devices have been found to intermittently turn on and off, Thu Sep 13 2012 By Other Author We paid over $1200 as I recall. 1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a "double click". All other trademarks are trademarks of their respective owners or holder. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable). d?;>)/nr;::!Tyb Q#Z@Z22lgwpM\Wwms$ToZm?KU=%9YWTc4#eiq@>vOOBU qRK5 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 . Friday or by email at RSRecall@stryker.com. 3) Inform the recalling firm of any of the subject devices have been distributed to other organizations. Note: If a Software Installation warning window is displayed when you attempt to download the Upgrader software, select the "Continue Anyway" option. Pad-Pak 01 & Pad-Pak 02 Adult Lot Numbers: A1785 to A1805 Pediatric Lot Numbers: P433 to P445. Exemption number (b)(4). Heartsine Samaritan 300P comes with the recall upgrade YES!!! 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.
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