BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1910065 · Received November 10, 2010

    Report

    Report Number
    1720753-2010-04036
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 10, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. PARTS HAVE BEEN ORDERED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6800 FLUOROSCOPY X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1