BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3871927 · Received April 17, 2014

    Report

    Report Number
    1720753-2014-03371
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 17, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM BUT NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE FE REPORTED INTERMITTENT X-RAY DISABLED ERROR MESSAGE ON BOOT-UP. THIS RESULTED IN AN INTERMITTENT RECOVERABLE LOSS OF FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236568 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1