BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4223508 · Received August 6, 2014

    Report

    Report Number
    1720753-2014-06765
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 MAINFRAME STEERING WAS DIFFICULT TO TURN. NO PATIENT DEATH OR SERVICE INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460417 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1