BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2153117 · Received June 17, 2011

    Report

    Report Number
    1720753-2011-08262
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FUSES NEED TO BE REPLACED. NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S IMAGE WOULD NOT COME UP ON THE MONITOR OUTSIDE OF A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1