BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3001864 · Received February 12, 2013

    Report

    Report Number
    1720753-2013-01705
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE X-RAY TUBE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A GENERATOR ERROR AND WOULD NOT PRODUCE X-RAYS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62176 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1