BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 PULSE OXIMETER

    MDR report key: 791021 · Received November 27, 2006

    Report

    Report Number
    2936999-2006-00893
    Event Type
    Malfunction
    Date Received
    November 27, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 25, 2006
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 10/25/2006 NELLCOR PURITAN BENNET RECEIVED A CALL FROM THE CUSTOMER REQUESTING THE MAIN PCB TO BE CHANGED. AT THE TIME THE CUSTOMER DID NOT HAVE THE FAILURE INFORMATION. DURING THE FAILURE INVESTIGATION ON 11/15/06, THE FAILURE OF NO AUDIO WAS FOUND. THE FAILURE WAS ISOLATED TO THE MAIN PCB. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA