BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSTAR

    MDR report key: 1474863 · Received June 19, 2009

    Report

    Report Number
    9680959-2009-00225
    Event Type
    Malfunction
    Date Received
    June 19, 2009
    Date of Event
    May 21, 2009
    Report Date
    June 16, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. DAP (DOSE RATE). THE GE SERVICE REP CHECKED AND RECALIBRATED THE DAP. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PHYSICIST'S QUERIED DAP READINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1