BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2600

    MDR report key: 1031033 · Received April 17, 2008

    Report

    Report Number
    1720753-2008-20617
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYS FAILS TO BOOT UP. 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