BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3862883 · Received February 20, 2014

    Report

    Report Number
    1720753-2014-01693
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE COIN BATTERY AND DISPLAY ADAPTOR WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE LEFT MONITOR INTERMITTENTLY FAILED TO DISPLAY IMAGE. THIS ISSUE WOULD PREVENT THE LIVE IMAGE FROM BEING VIEWED, THEREBY MAKING THE SYSTEM UNUSABLE. 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
    106597 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1