BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800 UROVIEW

    MDR report key: 2954153 · Received November 16, 2007

    Report

    Report Number
    1720753-2007-08905
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    June 15, 2007
    Report Date
    November 8, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE (B)(4) SERVICE REP INVESTIGATED THE ISSUE AND REMOVED AND REPLACED THE BROKEN ON/OFF SWITCH TO RESTORE FUNCTION. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE. NO PT INJURY OF HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.

    Description of Event or Problem · 1

    THE GE (B)(4) 2800 FLUOROSCOPY SYSTEM HAD A BROKEN ON/OFF SWITCH. SYSTEM COULD NOT BE TURNED ON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1