BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2031219 · Received March 16, 2011

    Report

    Report Number
    1720753-2011-02374
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED. THE SYSTEM WAS TESTED AND IS NOT OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD NOT PRODUCE AN IMAGE IN THE OBLIQUE POSITION. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1