BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 350P AND PAD PAK

    MDR report key: 6735512 · Received July 24, 2017

    Report

    Report Number
    3004123209-2017-00728
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 30, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 350P 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 350P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 20TH OF MAY 2014. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2014 AND THAT IT HAD PERFORMED ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON (B)(6) 2015. THE RETURNED PAD-PAK WAS INSTALLED AND THE DEVICE FAILED TO POWER ON. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND UPON VISUAL INSPECTION THE BATTERY WAS OBSERVED TO BE SEVERELY BLOWN WITH SILVER PARTICLES OBSERVED ACROSS THE COMPONENTS ON THE UPPER AND LOWER SIDE OF THE PCB. AFTER EXTENSIVE INVESTIGATION, A TRANSISTOR WHICH IS PART OF THE STATUS LED CIRCUITRY WAS FOUND TO HAVE FAILED WHICH LED TO THE GREEN STATUS LED REMAINING CONSTANTLY LIT. THIS TRANSISTOR WAS REPLACED AND THE FAULT CLEARED. AS STATUS LEDS ARE TESTED PRIOR TO DISPATCH IT IS ASSUMED THAT THE TRANSISTOR AND COIN CELL HAD FAILED AFTER FINAL TEST AT HEARSTINE ON (B)(6) 2014. SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519143 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1