BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1071189 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22945
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 26, 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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATOR FAILURE HAPPENED DURING A CASE AND CASE WAS NOT COMPLETED. CUSTOMER UNAWARE IF ANOTHER UNIT WAS USED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1