BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2884828 · Received December 3, 2012

    Report

    Report Number
    1720753-2012-09925
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 30, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY TRIED TO MAKE AN EXPOSURE, THE SYSTEM DISPLAYED AN OVERFREQUENCY FAULT ERROR MESSAGE AND EXPERIENCED A LOSS OF FUNCTIONALITY. THE SYSTEM WAS REMOVED FROM SERVICE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1