BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802660 · Received February 25, 2014

    Report

    Report Number
    1720753-2014-01787
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELLED THE SERVICE CALL PRIOR TO THE SYSTEM BEING ABLE TO BE EVALUATED. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS INTERMITTENTLY BLACK. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116163 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1