BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 9800 # 89-1023

    MDR report key: 1711178 · Received May 24, 2010

    Report

    Report Number
    1720753-2010-01577
    Event Type
    Malfunction
    Date Received
    May 24, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 24, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE LEFT MONITOR SHOWS PATIENT DATA BUT NOT AN IMAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 9800 # 89-1023 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1