BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 9800

    MDR report key: 1445794 · Received August 24, 2009

    Report

    Report Number
    1720753-2009-04671
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 18, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM, AND DETERMINED THE SINGLEBOARD COMPUTER NEEDS TO BE REPLACED. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SBC WAS NOT WORKING PROPERLY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1