BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3042652 · Received April 2, 2013

    Report

    Report Number
    1720753-2013-04496
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REMOTE USER INTERFACE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A MOTION ERROR AFTER BOOTED UP. THE ENGINEER STATED THAT THE LEFT REMOTE USER INTERFACE WAS NOT WORKING. THEREFORE, THIS WAS A COMPLETELY LOSS OF MOTORIZED C-ARM MOVEMENTS. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134866 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1