BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE OEC 9800

    MDR report key: 1033119 · Received April 23, 2008

    Report

    Report Number
    1720753-2008-20847
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND RESEATED THE INTERLOCK CONNECTIONS. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYS DISPLAYED AN INTERLOCK FAILED ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1