BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002175 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00392
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    February 5, 2012
    Report Date
    January 21, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2012. ON (B)(6) 2012 THE DEVICE FAILED A WEEKLY SELF TEST DUE TO A LOW BATTERY. THE DEVICE REMAINED IN FAULT MODE UNTIL (B)(6) 2012. A NEW PAD-PAK WAS INSERTED BUT THE DEVICE STARTS TO SWITCH ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. THE DEVICE FAILED A SELF TEST DUE TO A LOW BATTERY WHICH TRIGGERED THE BATTERY MANAGEMENT SYSTEM. THE LOW BATTERY WAS ALMOST CERTAINLY CAUSED BY THE EXPOSURE TO VERY LOW TEMPERATURES. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED 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 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
    60130 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1