BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2191622 · Received July 20, 2011

    Report

    Report Number
    1720753-2011-20243
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 20, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE ISSUE. THE SYSTEM WAS CLEANED AND THE CONNECTORS AND BOARDS IN THE WORKSTATION WERE RESEATED. THE VOLTAGES WERE CHECKED AND ADJUSTED AT THE FLUORO FUNCTIONS BOARD, THE DOGHOUSE, THE BACKPLANE, THE WORKSTATION AND THE VIDEO CONTROL PRINTED CIRCUIT BOARD. THE NETWORK CONNECTIVITY WAS CHECKED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN UNCOMMANDED AND DISPLAYED COMMUNICATION WITH WORKSTATION ERROR MESSAGES, AND THE PACS SYSTEM WOULD NOT WORK. NO PT INJURY WAS REPORTED.

    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