BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3101487 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05593
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    August 30, 2012
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE JOYSTICK. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE USER INTERFACE, (RUI), WAS NOT WORKING WHICH LEAD TO A LOSS OF MOTORIZED MOVEMENT. WHEN THE MOTORIZED MOVEMENTS ARE COMPLETELY DOWN, THE CRANIAL AND CAUDAL MOVEMENTS ARE NOT AVAILABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193136 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1