BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3791810 · Received January 6, 2014

    Report

    Report Number
    1720753-2014-00115
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    November 13, 2013
    Report Date
    January 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE EVALUATED AND RELOADED. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO ALLOW FLUOROSCOPIC EXPOSURES 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
    8663 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1