BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3171974 · Received June 10, 2013

    Report

    Report Number
    1720753-2013-06930
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM INTERMITTENTLY HAD NO IMAGE. THIS ISSUE WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE INABILITY TO SEE THE LIVE IMAGE. 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
    261632 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1