BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892398 · Received November 30, 2012

    Report

    Report Number
    3004123209-2012-00084
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    August 16, 2012
    Report Date
    November 5, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2010 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFORMATION OBTAINED FROM THE DEVICE SHOWED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY RESULTING IN MANUAL POWER-UPS OF TEN MINUTES IN DURATION OCCURRING BETWEEN (B)(6) 2012. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE DEVICE MEMBRANE. THIS FAULT CAUSED THE DEVICE TO SWITCH ON AUTOMATICALLY, WHICH CAUSED THE EARLY DEPLETION OF THE PAD PAK (LOT 702). PAD PAK (LOT 702) HAD A USE UNTIL DATE OF 08/2013. 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, WHICH IS WHY THE "UNKNOWN" BOX HAS BEEN CHECKED IN THIS REPORT.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ON AUTOMATICALLY AND THE DEVICE WAS EMITTING A "MEMORY FULL" WARNING MESSAGE. 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