BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1921652 · Received December 7, 2010

    Report

    Report Number
    1720753-2010-04496
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE LEG EXTENSIONS AND SENSORS WERE CLEANED AND ADJUSTED 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 THE 2800 SYSTEM HAD A INSTALLATION ERROR AND WOULD NOT DOCK THE FILM DURING A CASE. THE 2800 SYSTEM HAD TO BE REBOOTED AND THE PROCEDURE WAS COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1