BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 CHILD ASSY

    MDR report key: 709773 · Received May 5, 2006

    Report

    Report Number
    2936999-2006-00527
    Event Type
    Malfunction
    Date Received
    May 5, 2006
    Date of Event
    April 10, 2006
    Report Date
    April 10, 2006
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A FAILURE INVESTIGATION ON 05/04/2006, THE FAILURE OF NO AUDIO WAS CONFIRMED. THE FAILURE WAS ISOLATED TO THE MAIN PCB. THIS IS NOT ASSOCIATED WITH (Z-0664-05). THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N595 CHILD ASSY CHILD ASSY DQA NELLCOR PURITAN BENNETT N-595 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA