BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3011076 · Received March 14, 2013

    Report

    Report Number
    1720753-2013-03792
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE TEMPERATURE SENSOR AND THE COLLIMATOR WERE REPLACED AND THE COLLIMATOR WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SYSTEM DISPLAYED A COLLIMATOR IRIS POTENTIOMETER ERROR UPON BOOT UP. THIS ERROR PREVENTED THE SYSTEM FROM PERFORMING FLUOROSCOPY X-RAY AND THE SYSTEM HAD TO BE REBOOTED. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108403 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1