BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3980069 · Received July 2, 2014

    Report

    Report Number
    1720753-2014-05659
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE INTELLIGENT ORBITAL SERVO DRIVER WAS EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOSS OF MOTORIZED MOVEMENT FUNCTIONALITY. NO PT OR USER INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388390 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1