BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3963426 · Received May 30, 2014

    Report

    Report Number
    1720753-2014-04590
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MAINFRAME BATTERY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE SYSTEM DISPLAYED CHARGER FAILED ERROR WHICH PREVENTED THE SYSTEM FROM FUNCTIONING UNTIL IT WAS REBOOTED. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319962 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1