BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3960416 · Received June 9, 2014

    Report

    Report Number
    1720753-2014-04837
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 9, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO HAVE THE SERVICE REP FIX THE SYSTEM. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTER-MIXED PT IMAGE DATA. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335051 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1