BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3142702 · Received May 24, 2013

    Report

    Report Number
    1720753-2013-06427
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    March 4, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE X-RAY TUBE AND PERFORMED SYSTEM CALIBRATIONS. THE SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS DISPLAYED ERRORS AND WOULD NOT PRODUCE X-RAYS. A SYSTEM RESTART WAS REQUIRED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232176 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1