BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1693203 · Received May 6, 2010

    Report

    Report Number
    1720753-2010-01387
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    October 5, 2009
    Report Date
    May 6, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CANCELED THE SERVICE CALL. ATTEMPTS WERE MADE TO OBTAIN MORE INFO ON 04/12/2010, 04/22/2010, 04/28/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM DURING OPERATION BURNED OUT AND STARTED EMITTING SMOKE. 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