BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5090478 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01217
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 28, 2015
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN JANUARY 2010 AND PERFORMED TO SPECIFICATION UP TO 19TH OCTOBER 2014. DURING THIS TIME A NEW PAD-PAK WAS INSTALLED. MULTIPLE MANUAL POWER UPS, MAINLY OF TEN MINUTES DURATION WERE RECORDED ON THE 24TH OCTOBER 2014. THE PAD-PAK WAS THEN REMOVED FROM THE DEVICE. ON THE 13TH JANUARY 2015 A PAD-PAK WAS INSTALLED AND THE DEVICE PASSED AN AUTO SELF-TEST FOLLOWED BY A SUCCESSFUL MANUAL POWER UP. FURTHER MULTIPLE MANUAL POWER UPS, MAINLY OF TEN MINUTES DURATION WERE OBSERVED BETWEEN THE 27TH JULY 2015 AND THE FINAL LOG ENTRY ON THE 15TH SEPTEMBER 2015. DURING THIS TIME AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623886 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1