BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 2850634 · Received November 27, 2012

    Report

    Report Number
    1720753-2012-09677
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 27, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM'S COMPUTER WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN "NVRAM" ERROR MESSAGE AND WOULD NOT BOOT UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500

    Patients

    Seq Age Sex Outcome Treatment
    1