BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IT2500

    MDR report key: 3823267 · Received February 19, 2014

    Report

    Report Number
    1720753-2014-01673
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. HOWEVER, NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFORMATION IS UNAVAILABLE AT THIS TIME AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO POWER TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105038 IT2500 RADIOLOGICAL IMAGE PROCESSING JAA GE OEC MEDICAL SYSTEMS (SLC) IT2500

    Patients

    Seq Age Sex Outcome Treatment
    1