BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915268 · Received December 19, 2012

    Report

    Report Number
    3004123209-2012-00184
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 3, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THIS DEVICE IDENTIFIED A BROKEN +VET TERMINAL POGO PIN, WHICH WOULD HAVE CAUSED THE DEVICE NOT TO POWER-ON AS REPORTED IN THIS EVENT. DATA OBTAINED FROM THE DEVICE HISTORY CONFIRMED THAT THIS DEVICE HAD BEEN SUCCESSFULLY INSTALLED BY THE CUSTOMER IN (B)(6) 2009 AND DATA IS AVAILABLE FROM THIS DATE UP TO (B)(6) 2012. IT IS CONCLUDED, THEREFORE THAT THE DAMAGE TO THE POGO PIN WAS INCURRED FOLLOWING THE INCORRECT INSERTION OF THE PAD-PAK. VISUAL INSPECTION IDENTIFIED CORROSION ON THE USB CONTACTS AND ENCLOSURE SCREWS AND ROUTINE TESTING CONFIRMED THAT THIS DEVICE HAS BEEN STORED OUTSIDE THE RECOMMENDED STORAGE CONDITIONS (0 DEGREES CELSIUS TO 50 DEGREES CELSIUS/32F TO 122F). THERE WAS ALSO EVIDENCE THAT THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY, RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING ON (B)(6) 2012 AND CONTINUED CONSISTENTLY UP TO (B)(6) 2012. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE MEMBRANE, WHICH WOULD HAVE BEEN CAUSED BY THE ADVERSE STORAGE CONDITIONS TO WHICH THE DEVICE WAS EXPOSED TO. THE DEVICE SWITCHING ON AUTOMATICALLY CAN CONTRIBUTE TO THE EARLY DEPLETION OF THE PAD-PACKS. NO PAD-PACKS WERE RETURNED WITH THE DEVICE AND WERE NOT TESTED AS PART OF THIS INVESTIGATION. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE SUE 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1