BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 3063560 · Received April 12, 2013

    Report

    Report Number
    1720753-2013-04910
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 12, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE HARD DRIVE AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157673 ENTRAK 2500 RADIOLOGY IMAGE PROCESSING LLZ GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500

    Patients

    Seq Age Sex Outcome Treatment
    1