BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2960860 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01282
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY VOLTAGE WAS ADJUSTED, THE POWER SIGNAL INTERFACE CABLE AND INTERCONNECT CABLE WERE REPLACED. SEVERAL POWER CONNECTORS WERE RETIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY DISPLAY A COMMUNICATION FAILURE ERROR MESSAGE AND THE SYSTEM WOULD STOP PRODUCING FLUOROSCOPIC X-RAY. THE SYSTEM WAS LOCKING UP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39992 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1