BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRAK 2500P

    MDR report key: 2031314 · Received March 16, 2011

    Report

    Report Number
    1720753-2011-02441
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 12, 2011
    Report Date
    March 16, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RAN THE FILE SYSTEM CHECK (FSCK) DIAGNOSTIC AND REPAIR PROGRAM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1