BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITRACK 3500

    MDR report key: 3182554 · Received June 14, 2013

    Report

    Report Number
    1720753-2013-07107
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CMOS BATTERY WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272308 ITRACK 3500 RADIOLOGICAL IMAGE PROCESSING JAA GE OEC MEDICAL SYSTEMS (SLC) ITRACK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1