BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1880043 · Received October 13, 2010

    Report

    Report Number
    1720753-2010-03549
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 13, 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 REP EVALUATED THE SYSTEM AND ORDERED A REPLACEMENT MONOBLOCK (X-RAY TUBE) ASSEMBLY. IT IS ANTICIPATED THAT REPLACEMENT OF THE MONOBLOCK WILL RETURN THE SYSTEM TO OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM STOPPED WORKING DURING A PROCEDURE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1