BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1872282 · Received October 12, 2010

    Report

    Report Number
    1720753-2010-03499
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FOOTSWITCH WAS FOUND INOPERABLE AND THEREFORE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A FATAL ERROR AND THEN LOCKED 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