BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4844570 · Received June 11, 2015

    Report

    Report Number
    1720753-2015-02409
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 11, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE RTOS (REAL TIME OPERATING SYSTEM) CPU ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381101 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900 ES-1077

    Patients

    Seq Age Sex Outcome Treatment
    1