BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2043033 · Received March 25, 2011

    Report

    Report Number
    9680959-2011-00880
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 25, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP CONDUCTED AN ONSITE INVESTIGATION. THE OUTPUT CABLE FROM THE LEFT SCREEN WAS USED WITH THE RIGHT SCREEN. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT SCREEN WAS BROKEN AND THE RIGHT SCREEN WOULD NOT WORK ON THE 7900 SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1