BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3962938 · Received June 11, 2014

    Report

    Report Number
    1720753-2014-04948
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED, AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED A 24-HOUR RECHARGE REQUIRED ERROR MESSAGE. THE FUNCTIONALITY WAS RECOVERED WITH A REBOOT. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345027 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1