BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 2102894 · Received May 3, 2011

    Report

    Report Number
    2936999-2011-00305
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTH
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER HAS SWAPPING THE SPEAKER ASSEMBLY WITH NO CHANGE INDICATING FAULT TO THE MAIN BOARD. MANUFACTURING PREVIOUSLY INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH MANUFACTURING CONFIRMED FAILURES ISOLATED TO THE MAIN PCB. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1