BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1880041 · Received October 13, 2010

    Report

    Report Number
    9680959-2010-00390
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    July 28, 2010
    Report Date
    October 13, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN OVER THE PHONE INVESTIGATION. THE MONITOR SYNCRO WAS RESTORED DURING THE SERVICE CALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 7700 SYSTEM HAD POOR IMAGE QUALITY WITH BLURRY IMAGES. 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