BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2881049 · Received November 9, 2012

    Report

    Report Number
    3003793491-2012-00278
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "THE DEVICE STOPPED COMPRESSIONS AND THE BOARD SHOWED THE USER ADVISORY 45 MESSAGE" WAS PARTIALLY CONFIRMED. THE BOARD WAS RUN WITH THE TEST MANIKIN FOR 30 MINUTES WITHOUT ANY ISSUES. HOWEVER, WHEN THE LARGE RESUSCITATION TEST FIXTURE (EQUAL TO A 250 POUND PATIENT) WAS USED, BOARD STOPPED AFTER A FEW COMPRESSIONS. POWER DISTRIBUTION BOARD WAS FOUND TO BE AT FAULT AND WAS REPLACED. IT SHOULD BE NOTED THAT ARCHIVE FILE INDICATED THAT ON THE DATE OF THE REPORTED EVENT ((B)(4) 2012), BEFORE THE DEVICE WAS SENT IN FOR SERVICE, IT RAN FOR 922 COMPRESSIONS (APPROXIMATELY 11 MINUTES) WITH NO ISSUES. BOARD PASSED FINAL TEST AFTER THE DISTRIBUTION BOARD WAS REPLACED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING A CARDIAC ARREST, THE DEVICE STOPPED COMPRESSIONS AND THE BOARD SHOWED THE USER ADVISORY 45 MESSAGE. CUSTOMER TRIED PULLING UP THE LIFEBAND TO TRY AND CLEAR THE MESSAGE BUT THE DEVICE STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other