BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1133619 · Received August 20, 2008

    Report

    Report Number
    1720753-2008-24884
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 20, 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

    THE GE REP CALIBRATED THE COLLIMATOR. THE COLLIMATOR IS WORKING AS INTENDED. HE ADJUSTED THE LEFT REAR BRAKE ON THE GENERATOR. THE BRAKES ARE ALSO WORKING AS INTENDED. HE REPLACED THE FRONT COVER ON WORKSTATION. SYSTEM WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A IRIS POT ERROR DISPLAYED ON THE C-ARM AND THE SYSTEM HAD TROUBLE WITH THE FOOT BREAK. THE CUSTOMER ALSO REQUESTED A FRONT COVER ON THE WORKSTATION TO BE REPLACED. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1