BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 8800

    MDR report key: 1021019 · Received March 28, 2008

    Report

    Report Number
    9617766-2008-00163
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    July 2, 2004
    Report Date
    March 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEM INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED THE INTERCONNECT CABLE. SYSTEM OPERATES AS INTENDED. THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED IS 890. PLEASE NOTE THE MDRS ASSOCIATED WITH THIS REPORT ARE FILED LATE IN RESPONSE TO THE REMEDIATION EFFORTS OF GE HEALTHCARE. THIS REPORT IS FILED UNDER THE FDA'S RETROSPECTIVE SUMMARY REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM WAS NOT BOOTING UP. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEM INC. 8800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1