BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3823440 · Received March 26, 2014

    Report

    Report Number
    1720753-2014-02679
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR DRIVE WAS EVALUATED AND REPLACED. A COMPLETE FILAMENT AND GENERATOR CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE FE REPORTED THAT THERE WAS A SATURATION FAULT ERROR. THIS MAY PREVENT THE SYSTEM FROM BOOTING UP. 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
    177861 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1