BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1011858 · Received March 11, 2008

    Report

    Report Number
    9680959-2008-00039
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFO AT THIS TIME. WHEN ADDITIONAL INFO IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MONITORS ON THE WORKSTATION OF THE 7700 SYSTEM HAVE A VERTICAL ROLL THAT WILL NOT STOP OR DISPLAY ANYTHING. THE MONITOR ON THE C-ARM WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 7700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK