BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3860917 · Received April 14, 2014

    Report

    Report Number
    1720753-2014-03204
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE L-ARM ASSEMBLY WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE L-ARM MOTOR WAS NOT WORKING CORRECTLY. THIS IS A LOSS OF MOTORIZED MOVEMENTS. COMPLETE LOSS OF MOTORIZED FUNCTIONALITY MAY RESULT IN INABILITY TO OBTAIN IMAGES. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228616 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1