BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915084 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00786
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    January 10, 2010
    Report Date
    December 12, 2012
    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 A FAILED SELF TEST ON (B)(6) 2010. THE TEMPERATURE AT THIS TIME WAS SUB ZERO. A NEW PAD-PAK WAS THEN INSERTED AND PERFORMED TO SPECIFICATION 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. THE PROBLEM WAS ATTRIBUTED TO A FAULT ON THE MEMBRANE. PREVIOUS EXPERIENCE HAS TOLD US THIS TYPE OF FAULT ON THE MEMBRANE IS CAUSED BY THE EFFECTS OF THE DEVICE BEING ADEQUATELY PROTECTED FROM ADVERSE ENVIRONMENTAL CONDITIONS, PARTICULARLY TO COLD AND DAMP. 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 THE DEVICE WOULD NOT POWER ON. A DEVICE IN THIS FAULT MODE, IF LEFT UNDETECTED, COULD RESULT IN THE FAILURE OF THE DEVICE TO PERFORM AS INTENDED IF REQUIRED.

    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