BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2776952 · Received September 28, 2012

    Report

    Report Number
    3003793491-2012-00031
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 27, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS REC¿D THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    PARAMEDICS REC¿D THE FOLLOWING ERROR CODES: 02 (COMPRESSION TRACKING ERROR), 18 (MAX TAKE-UP REVOLUTIONS EXCEEDED), AND 22 (POSITION SET POINT OUT OF RANGE). THEY TRIED TO TROUBLESHOOT THE AUTOPULSE BUT THE UNIT KEPT GIVING MULTIPLE ADVISORY CODES.

    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