BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRAK 2500

    MDR report key: 2041545 · Received March 24, 2011

    Report

    Report Number
    1720753-2011-02779
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RESET THE POWER SUPPLY. THE CUSTOMER CANCELLED THE SERVICE CALL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ENTRAK 2500 SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1