BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800

    MDR report key: 1153663 · Received September 11, 2008

    Report

    Report Number
    1720753-2008-22296
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 6, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ON SITE EVALUATION. THE REP TROUBLESHOOT AND FOUND THAT IF MONITOR WAS BUMPED WITH A HAND, IT WOULD BLINK ON AND OFF. REPLACED MONITOR AND TESTED UNIT. WORKING AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM'S RIGHT MONITOR ON THE TABLE WAS NOT WORKING. ALSO, WHEN FLUOROING NO IMAGES COME UP, THE SYSTEM ONLY DISPLAYS SEARCHING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 2800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1