BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2852540 · Received November 26, 2012

    Report

    Report Number
    3004123209-2012-00346
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Date of Event
    November 15, 2010
    Report Date
    November 14, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES, LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD DEVICE WAS INSTALLED ON (B)(6) 2008 AND OPERATED SUCCESSFULLY UNTIL A FAILED SELF-TEST ON (B)(6) 2010. THERE ARE MULTIPLE SELF-TEST FAILS AFTER THIS DATE AND THE DEVICE WAS LEFT IN FAILURE MODE. THE USER WAS ALERTED TO THE PROBLEM BY THE RED LED STATUS INDICATOR BEING ILLUMINATED AND AN AUDIBLE BEEP. THOUGH NO PROBLEM WAS FOUND WITH THE PAD DEVICE OR PAD-PAK THE CONCLUSION OF THE INVESTIGATION IS THAT PAD-PAK WAS SO DEPLETED IT TRIGGERED THE BATTERY MANAGEMENT SYSTEM IN THE DEVICE. PREVIOUS EXPERIENCE HAS SHOWN THIS TYPE OF FAULT CAN BE CAUSED BY INADEQUATE STORAGE OF THE PAD DEVICE WHERE IT CAN BE 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 THE STATUS INDICATOR WAS FLASHING RED AND THE DEVICE WAS EMITTING AN AUDIBLE BEEP. 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