BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2850519 · Received November 27, 2012

    Report

    Report Number
    1720753-2012-09686
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 27, 2012
    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 SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE DOGHOUSE RIBBON CABLE WAS RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CONTROL PANEL ERROR MESSAGE. THIS ERROR MESSAGE IS GENERATED WHEN THE SYSTEM CANNOT COMMUNICATE WITH THE C-ARM CONTROL PANELS AND WILL CAUSE THE SYSTEM TO IMMEDIATELY SHUT DOWN. THERE IS NO REPORT OF PT INJURY.

    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