BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITIATION SYSTEM MODEL 100

    MDR report key: 2902000 · Received November 8, 2012

    Report

    Report Number
    3003793491-2012-00169
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2011
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WHILE ON A PT THE AUTOPULSE RESUSCITATION SYSTEM DISPLAYED A USER ADVISORY MESSAGE OF UA21 (POSITION CHANGE DOES NOT COINCIDE WITH MOTOR DIRECTION). MANUAL CPR WAS INITIATED AND PT WAS REPORTED TO BE OK. THERE WAS NO REPORT OF A PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other