BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932920 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00137
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    March 24, 2011
    Report Date
    January 11, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE HAD 16 EVENTS RECORDED ON (B)(6) 2011. FURTHER INVESTIGATION REVEALED THE REAL TIME CLOCK IN THE DEVICE WAS STILL RECORDING THIS DATE. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A PROBLEM WITH THE COIN CELL WHICH POWERS THE REAL TIME CLOCK. THE COIN CELL WAS REPLACED AND THE CLOCK OPERATED TO SPEC. THE DEVICE ALSO POWERED ON AS NORMAL AND THE GREEN LED FLASHED NORMALLY. 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 PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE THE DEVICE WOULD NOT POWER-ON. 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
    33402 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1