BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1014283 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17926
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE FLUORO FUNCTION BOARD, REBUILT NODES AND RELOADED THE CONFIGURATION DATA. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACE BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY THE 9900 SYSTEM C-ARM REBOOTS. THERE WAS 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, INC. 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1