BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1900412 · Received October 26, 2010

    Report

    Report Number
    1720753-2010-03772
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 26, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE PS2 POWER SUPPLY 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 9900 SYSTEM HAD POOR IMAGE QUALITY DURING A CASE. THE 9900 SYSTEM HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1