BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3911865 · Received May 13, 2014

    Report

    Report Number
    1720753-2014-04120
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED 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

    IT WAS REPORTED THAT THE SYSTEM HAD A POPPING NOISE DURING THE PROCEDURE, THEN IT WOULD NOT X-RAY. THIS WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO THE LOSS OF THE LIVE IMAGE. 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
    285633 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1