BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2770588 · Received October 1, 2012

    Report

    Report Number
    1720753-2012-07769
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 1, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PERFORMED A FILAMENT CALIBRATION. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT PRODUCE A USABLE LIVE FLUOROSCOPIC IMAGE. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    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