BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2943149 · Received December 13, 2012

    Report

    Report Number
    3003793491-2012-00491
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    July 2, 2012
    Report Date
    August 3, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "BATTERY CONNECTOR DAMAGED, UA (USER ADVISORY ) 16 INDICATED, BATTERY LOCK LATCH AND SCREW MISSING" WAS VERIFIED. USER ADVISORY 16 (TIME OUT MOVING TO TAKE-UP POSITION) WAS DUE TO A NON-FUNCTIONING DRIVETRAIN MOTOR. NORMAL WEAR AND TEAR MAY HAVE CAUSED THE DRIVETRAIN MOTOR TO FAIL AS THE PLATFORM IS OVER 4 YEARS OLD. DRIVETRAIN MOTOR WAS REPLACED AND ALL REQUIRED TESTS WERE COMPLETED. PLATFORM PASSED FINAL TEST. THE DAMAGED BATTERY CONNECTOR, AND THE MISSING BATTERY LOCK LATCH AND SCREW WERE MOST LIKELY CAUSED BY PHYSICAL DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BATTERY CONNECTOR DAMAGED, USER ADVISORY 16 WAS INDICATED, AND BATTERY LOCK LATCH AND SCREW WERE MISSING. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other