BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 1140843 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24319
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 5, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP ERASED NODES AND RELOADED CAL FILES. SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A RIGHT AND LEFT COMMUNICATION FAILURE ERROR DISPLAYED ON THE SYSTEM. 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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1