BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROVIEW

    MDR report key: 1791372 · Received August 6, 2010

    Report

    Report Number
    1720753-2010-02365
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE TABLE MOTOR DRIVE CONNECTORS WERE CLEANED. THE SYSTEM WAS THEN FOUND TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO MOVE LATERALLY. NO REPORT OF PT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UROVIEW FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2600

    Patients

    Seq Age Sex Outcome Treatment
    1