BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2062877 · Received March 21, 2011

    Report

    Report Number
    1720753-2011-02550
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE VIDEO CONTROLLER PCB WAS REPLACED. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MONITOR ON THE 9800 WOULD INTERMITTENTLY GO BLACK. NO PATIENT 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