BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4122078 · Received September 19, 2014

    Report

    Report Number
    1720753-2014-08015
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM SOFTWARE AND CALIBRATION WERE EVALUATED AND REPAIRED THROUGH THE (FSCK) FILES SYSTEM CHECK PROCESS. 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 FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583366 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1