BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3182462 · Received June 14, 2013

    Report

    Report Number
    1720753-2013-07149
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE LEFT MONITOR WAS REPLACED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS LEFT MONITOR WOULD GO TO SLEEP MODE AND THEN THE CUSTOMER HAD TO REBOOT THE SYS TO GET IT TO WORK AGAIN. THIS MAY CAUSE THE SYS TO BECOME INTERMITTENTLY UNUSABLE DUE TO THE LOSS OF THE LIVE FLUOROSCOPIC IMAGE. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271813 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1