BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2041438 · Received March 24, 2011

    Report

    Report Number
    1720753-2011-02727
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND THE CUSTOMER CANCELLED THE SERVICE CALL. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 2800 SYSTEM PRODUCED A GENERATOR SYSTEMS ERROR. 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