BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 3201313 · Received June 26, 2013

    Report

    Report Number
    9680959-2013-01274
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WORKSTATION MONITOR INTERMITTENTLY FAILED TO DISPLAY FLUORO IMAGE. THIS CAUSED AN INTERMITTENT LOSS OF LIVE FLUOROSCOPIC IMAGES WHICH COULD CAUSE THE SYSTEM TO BECOME INTERMITTENTLY UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289479 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1