BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3101492 · Received May 2, 2013

    Report

    Report Number
    1720753-2013-05588
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPAIRED AND RESEATED THE RUI PLUG CONNECTOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RUI (REMOTE USER INTERFACE/JOYSTICK) COULD NOT BE CONNECTED TO THE SYSTEM. THIS RESULTED IN A LOSS OF MOTORIZED MOTION. 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 THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193165 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1