BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2841440 · Received October 23, 2012

    Report

    Report Number
    3003793491-2012-00174
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N) (B)(4) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. VISUAL INSPECTION OF THE PLATFORM REVEALED A DAMAGED BATTERY LOCK. THE BATTERY LOCK WAS REPLACED. THE REPORTED PROBLEM OF USER ADVISORY 8 (MOTOR CONTROLLER FAULT DETECTED) WAS NOT CONFIRMED. THE PLATFORM WAS INSPECTED AND TESTED BY A TRAINED ZOLL SERVICE REPRESENTATIVE AND NO SYSTEM MALFUNCTION WAS FOUND. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE BOARD IS SHOWING USER ADVISORY 8 THAT CANNOT CLEARED.

    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