BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932566 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00054
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    February 28, 2010
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2009 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. AFTER THIS DATE THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY AND CONTINUES IN THIS WAY UNTIL (B)(6) 2010. THE NEXT EVENT IS (B)(6) 2011 WHICH MEANS THE DEVICE WAS LEFT IN FAULT MODE OR THE PAD-PAK WAS REMOVED. A NEW PAD-PAK WAS INSTALLED AND AGAIN THE DEVICE SWITCHES ITSELF ON. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. THERE IS ALSO EVIDENCE THAT THE DEVICE WAS BEING STORED IN A LOCATION WHERE IT WAS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS WHICH CAN HAVE A DETRIMENTAL EFFECT ON THE DEVICE MEMBRANE. 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 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
    33415 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1