BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2823637 · Received September 25, 2009

    Report

    Report Number
    1720753-2009-06995
    Event Type
    Malfunction
    Date Received
    September 25, 2009
    Date of Event
    September 7, 2009
    Report Date
    September 18, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM IS DISPLAYING A PRECHARGE VOLTAGE ERROR. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1