BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTA TRAK 3500

    MDR report key: 2193524 · Received July 21, 2011

    Report

    Report Number
    1720753-2011-20280
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM PT'S DATA SET WOULD NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTA TRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS INSTA TRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1