BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE OEC 2600

    MDR report key: 1033118 · Received April 23, 2008

    Report

    Report Number
    1720753-2008-20846
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE BATTERIES. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT FILM SHOTS ARE COMING OUT GRAINY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC 2600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1