BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3101458 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05585
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. ALL MAINFRAME CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A CASE, THE DISPLAYED LIVE IMAGE BECAME DARK AND UNUSABLE. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193162 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1