BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3902793 · Received May 9, 2014

    Report

    Report Number
    1720753-2014-04076
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 9, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    IT WAS REPORTED THAT THE SYSTEM STOPPED WORKING WITHOUT COMMAND. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281773 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1