BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2920210 · Received December 17, 2012

    Report

    Report Number
    3003793491-2012-00513
    Event Type
    Malfunction
    Date Received
    December 17, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED COMPLAINT OF "USER ADVISORY 45" (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) WAS CONFIRMED. DRIVE SHAFT WAS ROTATED BACK TO HOME POSITION; THIS RESOLVED THE COMPLAINT. FURTHERMORE, TOP COVER AND FRONT ENCLOSURE WERE CRACKED AND BATTERY LOCK WAS MISSING. DAMAGED/MISSING PARTS WERE REPLACED; PLATFORM PASSED FINAL TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED : "UA45" (USER ADVISORY 45). 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. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other