BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3833014 · Received March 25, 2014

    Report

    Report Number
    1720753-2014-02674
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 20, 2014
    Report Date
    March 25, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE LEFT MONITOR WAS EVALUATED AND REPLACED WITH ANOTHER FROM A DIFFERENT PRODUCT. THE DEVICE REQUIRED ADDITIONAL REPAIR TO RESTORE IT TO A STATE OF FUNCTIONALITY. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFO WAS PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FUNCTIONALITY WAS LOST FROM THE LEFT "LIVE" MONITOR. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173778 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1