BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 PULSE OXIMETER

    MDR report key: 1040625 · Received May 7, 2008

    Report

    Report Number
    2936999-2008-00230
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 5, 2008
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS REQUESTED BACK FOR EVALUATION, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    COVIDIEN FORMERLY TYCO HEALTHCARE RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. THIS HAPPENED DURING THE PREVENTATIVE MAINTENANCE, AND NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N595 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN N595

    Patients

    Seq Age Sex Outcome Treatment
    1