BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2889348 · Received November 16, 2012

    Report

    Report Number
    3004123209-2012-00313
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    August 19, 2010
    Report Date
    November 13, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY INSTALLED ON 10/03/2007 AND APPEARS TO PERFORM AS EXPECTED UNTIL 07/18/2010. AFTER THIS DATE THE DEVICE BEGINS TO SWITCH ITSELF ON AND OFF AUTOMATICALLY, TIMING OTU AND CAN LEAD TO THE DEPLETING OF THE PAD-PAK. THE DEVICE DID EMIT A MEMORY FULL AND LOW BATTERY WARNING ON 07/18/2010. THE PROBLEM WITH THE DEVICE WAS TRACED TO A FAULTY MEMBRANE BUT DID PERFORM AS EXPECTED FROM DATE OF FIRST INSTALLATION UNTIL 07/18/2010. 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 PATIENT 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