BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2202188 · Received August 5, 2011

    Report

    Report Number
    1720753-2011-20741
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 5, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP WAS UNABLE TO DUPLICATE THE ERROR BUT RECALIBRATED THE GENERATOR AS A PRECAUTIONARY MEASURE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED INTERMITTENT REGULATOR FAILURE MESSAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1