BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1934287 · Received November 24, 2010

    Report

    Report Number
    9680959-2010-00536
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    May 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS REPAIRED BY THE SVC ENGINEER OVER THE PHONE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM'S MONITOR FLICKERED THEN FAILED TO DISPLAY AN IMAGE. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1