BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3963036 · Received June 23, 2014

    Report

    Report Number
    1720753-2014-05330
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEFT MONITOR HAD NO VIDEO IMAGE DURING START UP AND THE SYSTEM FROZE ON THE 5 ARROWS. THIS WAS LIKELY A SYSTEM LOCK UP. THERE ARE NO REPORTS OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366098 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1