BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTATRAK 3500

    MDR report key: 3791986 · Received January 14, 2014

    Report

    Report Number
    1720753-2014-00502
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED A REMOTE INVESTIGATION. THE SYSTEM WAS EVALUATED AND THE USER WAS ASKED TO REBOOT THE SYSTEM. SYSTEM FUNCTIONALITY WAS RESTORED AND THE SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY FAILED TO BOOT TO A USABLE STATE AND EXHIBITED INTERMITTENT FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35991 INSTATRAK 3500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) INSTATRAK 3500

    Patients

    Seq Age Sex Outcome Treatment
    1