BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 2090714 · Received April 26, 2011

    Report

    Report Number
    1720753-2011-06612
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S SERVICE REPRESENTATIVE INSTRUCTED THE CUSTOMER TO SHUT DOWN AND REBOOT THE SYSTEM. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

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

    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