BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6840890 · Received September 4, 2017

    Report

    Report Number
    3004123209-2017-00906
    Event Type
    Malfunction
    Date Received
    September 4, 2017
    Date of Event
    August 9, 2017
    Report Date
    September 28, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DISPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON 6TH FEBRUARY 2012. ON RECEIPT OF THE DEVICE THE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2016 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2017. BETWEEN (B)(6) 2017, THE DEVICE BEGAN TO PERFORM MULTIPLE POWER UPS OF MAINLY TEN MINUTES DURATION. DURING THIS TIME, THE PAD-PAK BECAME DEPLETED AND THE DEVICE ENTERED CPR ASSIST MODE. AFTER FURTHER INVESTIGATION, IT WAS FOUND THAT THE MEMBRANE OF THE DEVICE HAD FAILED DUE TO CORROSION, CAUSING A SHORT CIRCUIT RESULTING IN OVERVOLTAGE AND DAMAGE TO THE MICROPROCESSOR.

    Additional Manufacturer Narrative · 0

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

    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
    620937 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1