BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2193260 · Received July 13, 2011

    Report

    Report Number
    9680959-2011-01573
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 13, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPAIRED A CONNECTOR. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE IMAGE TURNS WHITE AND UNUSABLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1