BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE ESUSCITATION SYSTEM MODEL 100

    MDR report key: 2920209 · Received December 17, 2012

    Report

    Report Number
    3003793491-2012-00511
    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

    PLATFORM WAS RUN FOR 15 MINUTES, NO OPERATIONAL ISSUES WERE NOTED. FURTHERMORE, THERE WERE NO USER ADVISORIES NOTED IN THE PLATFORM'S ARCHIVE FILE. HOWEVER, INCOMING INSPECTION NOTED THAT HEAD RESTRAINT BRACKETS, FRONT ENCLOSURE, AND BATTERY LOCK WERE DAMAGED AND TWO SHOULDER (LOAD PLATE) SCREWS WERE MISSING. PARTS WERE REPLACED, LOAD PLATE SCREWS WERE INSTALLED. PLATFORM PASSED FINAL TEST. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATFORM FAILED, BUT NO DETAILS WERE PROVIDED. NO ADVERSE EVENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other