BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1071073 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22862
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE SERVICE REP PRFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. CHECKED VOLTAGE FROM WALL AND COMPARED IT TO TRANSFORMER TAP, ALL OK. VERIFIED TRANSFORMER TAP WITHIN SPECS. TIGHTEN THE RECEPTACLE ON THE POWER PLUG. BOOTED SYSTEM MULTIPLE TIMES AND VERIFIED SYSTEM IS OPERATING BY FLUOROING IN LOW AND HIGH TECHNIQUE BEFORE RETURNING BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNIT IS NOT BOOTING AND LOUD BEEPING NOISE COMING FROM THE WORKSTATION WHEN PLUGGING IT IN TO THE WALL OUTLET. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1