BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2901999 · Received November 8, 2012

    Report

    Report Number
    3003793491-2012-00171
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    June 11, 2012
    Report Date
    June 11, 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

    ZOLL MEDICAL CORP HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION. SEVERAL ATTEMPTS WERE MADE BY DEVICE MANUFACTURER TO OBTAIN STATUS OF PRODUCT RETURN. THESE EFFORTS HOWEVER WERE UNSUCCESSFUL. IF PRODUCT IS RETURNED TO THE MANUFACTURER, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PT CARE, THE AUTOPULSE RESUSCITATION SYSTEM DISPLAYED A USER ADVISORY MESSAGE OF UA19 (MAX APPLIED LOAD EXCEEDED). A FEW COMPRESSIONS WERE PERFORMED AND THEN THE UNIT SHUT OFF. MEDICS INDICATED THAT THE PTS' WEIGHT DID NOT EXCEED 300LBS AND MANUAL CPR HAD TO BE ADMINISTERED. THERE WAS NO REPORT OF A PT INJURY.

    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