BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 2022221 · Received February 28, 2011

    Report

    Report Number
    1720753-2011-01709
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 28, 2011
    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 REP PERFORMED AN ONSITE INVESTIGATION AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SERVICE REP OFFERED TO REPLACE THE X-RAY TUBE AS THE CAUSE OF INTERMITTENT PROBLEMS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 6800 SYSTEM WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1