BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 4782152 · Received April 24, 2015

    Report

    Report Number
    3004123209-2015-00456
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    April 22, 2015
    Report Date
    July 10, 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
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN AUGUST 2013 AND PERFORMED TO SPECIFICATION UP TO THE 21ST DECEMBER 2014. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION ARE RECORDED BETWEEN 21ST DECEMBER 2014 AND 22ND APRIL 2015. THE PAD-PAK BECAME DEPLETED AND A FURTHER PAD-PAK WAS INSTALLED. IT IS REASONABLE TO CONCLUDE THAT DEVICES RETURNED FOR THE REPORTED FAULT MAY BE ATTRIBUTED TO MEMBRANE FAILURE RESULTING IN MULTIPLE MANUAL POWER UPS OF TEN MINUTE TIME OUTS AND AN EXCESS CURRENT DRAIN WHICH WOULD HAVE CONTRIBUTED TO THE EARLY DEPLETION OF THE PAD-PAK. THIS WOULD CONFIRM THE REPORTED FAULT. THE DEVICE WAS OBSERVED SWITCHING ON DURING THE INVESTIGATION. THE GREEN LED REMAINING CONSTANTLY LIT DURING THE INVESTIGATION IS A FURTHER SYMPTOM OF MEMBRANE FAILURE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. NO PAD-PAK WAS RETURNED FOR INVESTIGATION. 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. THE DEVICE WAS MALFUNCTIONED AS THE DEVICE DEPLETING PAD-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274784 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1