BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3001879 · Received February 12, 2013

    Report

    Report Number
    1720753-2013-01710
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM SHUT DOWN, RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62179 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1