BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4142847 · Received September 30, 2014

    Report

    Report Number
    1720753-2014-08304
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MAINFRAME DISPLAYED A COLLIMATOR CAL REQUIRED ERROR MESSAGE ON BOOT UP. THE FIELD ENGINEER NOTED THAT THE COLLIMATOR CONED (CLOSED) DOWN. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607045 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1