BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1840132 · Received September 15, 2010

    Report

    Report Number
    1720753-2010-03092
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 15, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE ARO. A GE REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE COLLIMATOR TO WITHIN FEDERAL AND STATE SPECS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE BEAM EXCEEDS VISIBLE IMAGE BY 6.1% OF 23 SID ON MAG 1 ONLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1