BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3093420 · Received April 26, 2013

    Report

    Report Number
    1720753-2013-05380
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 26, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE FOLLOWING COMPONENTS WERE RESEATED: THE GIB RIBBON CABLE CONNECTOR, FLUORO FUNCTIONS BOARD AND ASSOCIATED CHIPS, AND THE ASSOCIATED POWER SUPPLY CONNECTORS. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DISPLAYED COMMUNICATION AND CONTROL PANEL ERROR MESSAGES. THEY REPORTED THAT THEY CAN GET IT TO TURN ON AND BOOT UP BUT AFTER A FEW PICTURES THE ERRORS WOULD COME UP. THE SYS WAS LIKELY EITHER LOCKING-UP OR SHUTTING DOWN. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181715 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1