BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3123933 · Received May 17, 2013

    Report

    Report Number
    1720753-2013-06134
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    March 13, 2013
    Report Date
    May 17, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE ORBITAL AND ROTATIONAL MOVEMENTS WERE RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE CRANIAL CAUDAL SOFTWARE VALUE MISMATCH WITH THE MECHANICAL VALUE. THIS LIKELY CAUSED A LOSS OF CRANIAL CAUDAL MOVEMENTS. THIS FEATURE IS CRITICAL FOR THIS TYPE OF C-ARM. THE SYSTEM WOULD EFFECTIVELY BE UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219468 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1