BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3042558 · Received April 2, 2013

    Report

    Report Number
    1720753-2013-04538
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 2, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONTROL PANEL CIRCUIT BOARD WAS REPLACED AND THE COLLIMATOR WAS RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE FIELD ENGINEER REPORTED THAT THE SYSTEM DISPLAYED "MONOBLOCK" AND "MA OR IN ERROR" ERROR MESSAGES. THESE ERROR MESSAGES MAY RENDER THE SYSTEM INOPERABLE AND / OR CAUSE THE SYSTEM TO SHUTDOWN UN-COMMANDED. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134404 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1