BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2932486 · Received January 23, 2013

    Report

    Report Number
    3004123209-2013-00041
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    May 15, 2011
    Report Date
    January 4, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2010 AND OPERATED SUCCESSFULLY UNTIL (B)(6) 2011. AFTER THIS DATE THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. A CLOSER INSPECTION OF THE DEVICE HISTORY LOG REVEALED THE TEMPERATURE AT THE TIME OF THE WEEKLY SELF TESTS WAS AS LOW AS -6.4 DEGREE C. EXPOSURE OF THE DEVICE TO ADVERSE ENVIRONMENT CONDITIONS CAN HAVE DETRIMENTAL EFFECTS ON THE 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 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
    33371 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD, CANBERRA HOUSE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1