BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 PULSE OXIMETER

    MDR report key: 724808 · Received June 12, 2006

    Report

    Report Number
    2936999-2006-00623
    Event Type
    Malfunction
    Date Received
    June 12, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    NELLCOR PURITAN BENNETT, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE INVESTIGATION FOUND THAT THE FAILURE WAS ISOLATED TO THE MAIN PCB.

    Description of Event or Problem · 1

    DURING THE FAILURE INVESTIGATION OF A CUSTOMER COMPLAINT ON 5/25/2006, IT WAS IDENTIFIED THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. 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, INC. N-595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Other