BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 3002169 · Received February 11, 2013

    Report

    Report Number
    3004123209-2013-00397
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    October 30, 2011
    Report Date
    January 21, 2013
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2011. THE DEVICE PASSED A SELF TEST AND THE PAD-PAK WAS REMOVED. ON (B)(6) 2011, THE PAD-PAK WAS RE-INSERTED AND THE DEVICE PASSED SELF TESTS AND AGAIN THE PAD-PAK WAS REMOVED. ON (B)(6) 2011, A PAD-PAK WAS INSERTED AND OPERATED TO SPECIFICATION UNTIL (B)(6) 2011. BETWEEN (B)(6) 2011 THERE ARE MULTIPLE MANUAL POWER-UPS, MAINLY OF 10 MINUTE DURATION, THE PAD-PAK IS THEN REMOVED. THE PATTERN OF REINSERTING AND REMOVING A PAD-PAK HAPPENS UP UNTIL (B)(6) 2012. THE MULTIPLE MANUAL POWER UPS INDICATE THE DEVICE IS SWITCHING ITSELF ON AUTOMATICALLY. THE PROBLEM WITH THE DEVICE WAS ATTRIBUTED TO A FAULT IN THE MEMBRANE. THE PAD PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P 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
    60129 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES, LTD PAD

    Patients

    Seq Age Sex Outcome Treatment
    1