BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892549 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00564
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    September 30, 2011
    Report Date
    November 26, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. AFTER THIS DATE THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE DEVICE WAS ALSO EXPOSED TO EXTREME TEMPERATURES OF 50 DEGREES C AND MORE. PREVIOUS EXPERIENCE HAS TOLD US THAT THE REPORTED SYMPTOMS CAN BE CAUSED BY A PROBLEM WITH THE DEVICE MEMBRANE. STORING THE PAD DEVICE AND PAD PAKS IN INADEQUATE CONDITIONS WHERE IT CAN BE EXPOSED TO ADVERSE CONDITIONS CAN ALSO AFFECT THE MEMBRANE. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P ARE FOR MULTI-USE.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IF LEFT UNDETECTED, COULD RESULT IN THE BATTERY BECOMING DEPLETED.

    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