BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3042600 · Received April 2, 2013

    Report

    Report Number
    1720753-2013-04521
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE JOYSTICK WAS REPLACED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF MOTORIZED MOVEMENTS. THIS FEATURE IS CRITICAL FOR THE TYPE OF IMAGING THE MOTORIZED C-ARM WAS DESIGNED FOR. THE SYSTEM WOULD BE EFFECTIVE UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134911 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1