BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2892396 · Received November 30, 2012

    Report

    Report Number
    3004123209-2012-00167
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    September 26, 2012
    Report Date
    November 15, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN (B)(6) 2009 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO (B)(6) 2012. THE INFO OBTAINED FROM THE DEVICE SHOWED THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY, RESULTING IN MANUAL POWER-UPS OF 10 MINUTES IN DURATION OCCURRING (B)(6) 2011 AND CONTINUED CONSISTENTLY UP TO (B)(6) 2011. A NEW PAD PAK WAS INSTALLED IN (B)(4) 2011 AND THE DEVICE RESUMED TO PERFORM TO SPECIFICATION UP TO (B)(4) 2012 WHEN THERE WAS EVIDENCE THE DEVICE STARTED TO SWITCH ITSELF ON AUTOMATICALLY. INVESTIGATION CONFIRMED THERE TO BE A FAULT WITH THE DEVICE MEMBRANE. THIS FAULT CAUSED THE DEVICE TO SWITCH ON AUTOMATICALLY. PAD PAK (LOT A1171) WAS FOUND TO HAVE DEPLETED IN LINE WITH NORMAL USAGE. 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 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