BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2852560 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00366
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    February 16, 2011
    Report Date
    November 16, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2010. THERE ARE MULTIPLE SELF-TEST FAILS AFTER THIS DATE INDICATING THE PAD DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE PAD DEVICE WAS ATTRIBUTED TO A FAULT WITH THE MEMBRANE. ON CLOSER INSPECTION SIGNIFICANT SIGNS OF CORROSION WERE FOUND ON THE MEMBRANE TAIL. THIS WOULD INDICATE THAT THE DEVICE MAY HAVE BEEN STORED IN A LOCATION WHERE IT IS EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. 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
    1 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATION MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1