BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3902134 · Received May 6, 2014

    Report

    Report Number
    1720753-2014-03950
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SVC CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER. NO ADD'L SVC INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE WENT BLACK. THIS COULD CAUSE PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271780 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1