BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9900

    MDR report key: 1083853 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24099
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYS AND REPLACED THE BATTERY PACK. SYS OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYS IS DISPLAYING A LOW MA ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. 9900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1