BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3123964 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06149
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICES REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. FUSE NUMBER FOUR WAS RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A MOVEMENT ERROR MESSAGE, CAUSING A LOSS OF MOTORIZED MOVEMENT. THE MOTORIZED MOVEMENTS ARE CRITICAL FOR THE TYPE OF IMAGING THE MOTORIZED C-RAM WAS DESIGNED FOR. THE SYSTEM WOULD EFFECTIVELY BE UNSTABLE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218636 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1