BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3124022 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06170
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE LEMO PIN CONNECTOR WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS NOT FLUOROING CORRECTLY. THE FSE FOUND THAT THE LIVE MONITOR LOOKED SPLIT. THIS COULD CAUSE THE SYSTEM TO BECOME UNUSABLE DUR TO TRUNCATED OR SPLIT IMAGES ON THE LIVE MONITOR. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218844 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1