BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932584 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00135
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    August 19, 2011
    Report Date
    January 10, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS DISASSEMBLED FOR INVESTIGATION AND A FAULT WITH THE COIN CELL WAS REVEALED. THE OLD COIN CELL WAS REPLACED AND A PAD-PAK RE-INSERTED INTO THE DEVICE. IT OPERATED SUCCESSFULLY AND THE GREEN STATUS INDICATOR FLASHED NORMALLY. THE COIN CELL IN THE DEVICE HAD BECOME DEPLETED BUT UNDER TESTING IT WAS CONFIRMED THAT THE DEVICE WAS STILL CAPABLE OF DELIVERING THERAPY. THE USER WAS ALERTED TO THE PROBLEM BY THE STATUS LED NOT BEING ILLUMINATED. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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. THIS DEVICE MALFUNCTIONED BECAUSE THE STATUS INDICATOR WAS NOT FLASHING. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33346 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1