BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2062043 · Received April 6, 2011

    Report

    Report Number
    1720753-2011-03286
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP REPLACED THE X-RAY TUBE AND CALIBRATED THE GENERATOR. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9800 SYSTEM PRODUCED TWO LOUD NOISES DURING FLUOROSCOPY AND DISPLAYED LOW MILLIAMP AND LOW KILOVOLT ERROR MESSAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1