BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915154 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00755
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 12, 2009
    Report Date
    December 10, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    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 26TH JANUARY 2008 AND OPERATED SUCCESSFULLY UNTIL (B)(4) 2009. AFTER THIS DATE, THERE ARE MULTIPLE EVENTS ON THE SAME DAY WHICH WOULD INDICATE THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. A NEW PAD-PAK WAS INSERTED BUT AGAIN THE DEVICE APPEARS TO BE FAILING SELF TESTS AND SWITCHING ON AUTOMATICALLY. THE DEVICE IS THEN MANUALLY POWERED ON 7 TIMES AND DURING THESE, THE USER WAS UNABLE TO TURN OFF THE DEVICE. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. THIS TYPE OF FAULT CAN BE CAUSED BY THE DEVICE BEING STORED IN AN INADEQUATE LOCATIION WHER IT CAN BE EXPOSED TO ADVERSE ENVIRONMENTAL CONDITIONS. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED 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 IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS DEPLETING PAD-PAKS AND NOT POWERING OFF. 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