BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2934559 · Received January 10, 2013

    Report

    Report Number
    1720753-2013-00479
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE POWER MOTOR RELAY BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A LOSS OF MOTORIZED MOVEMENTS. WHEN THE MOTORIZED MOVEMENTS ARE COMPLETELY DOWN, THE CRANIAL AND CAUDAL MOVEMENTS ARE NOT AVAILABLE. THIS IS CRITICAL FOR THE TYPE OF IMAGING THE MOTORIZED C-ARM WAS DESIGNED FOR. THE SYSTEM WOULD BE EFFECTIVELY UNUSABLE. THERE WAS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16217 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1