BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2960857 · Received January 11, 2013

    Report

    Report Number
    3003793491-2013-00049
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    April 2, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "LIFEBAND COULD NOT BE WOUND AND THE DEVICE IS MAKING A STRANGE NOISE" WAS CONFIRMED. THE DRIVETRAIN MOTOR WAS NOT OPERATING CORRECTLY BECAUSE THE BUSHING WAS SLIPPING. THIS CAUSED THE LIFEBAND NOT TO WIND AND MADE THE GRINDING NOISE. DRIVETRAIN MOTOR AS REPLACED, WHICH ALLEVIATED THE PROBLEM. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIFEBAND WOULD NOT WIND AND THAT THE PLATFORM WAS MAKING A STRANGE NOISE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17522 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other