BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3862895 · Received February 20, 2014

    Report

    Report Number
    1720753-2014-01691
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE FE SUSPECTED THAT THE CUSTOMER FAILED TO PROPERLY CONNECT THE INTERCONNECT CABLE. THE SYSTEM WAS TESTED AND FOUND TO WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106772 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1