BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800

    MDR report key: 1021694 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-18059
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 14, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP HAS NOT YET EVALUATED THE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM OUTPUT IS OVER 20R PER MINUTE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1