BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1926048 · Received November 10, 2010

    Report

    Report Number
    2936999-2010-01312
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/14/2010, NEW INFO WAS RECEIVED FROM SERVICE SITE INDICATING THAT DURING SERVICE REPAIR OF THE UNIT, NO AUDIO WAS OBSERVED AND ISOLATED TO A FAULTY SPEAKER. BASED ON THE NEW INFO, THE COMPLAINT HAS BEEN REVIEWED FOR DISPOSITION ON MDR REPORTING. THE SPEAKER ASSEMBLY WAS REPLACED AND THE UNIT PASSED ALL FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    ON 10/14/2010, NEW INFO WAS RECEIVED FROM SERVICE SITE INDICATING THAT DURING SERVICE REPAIR OF THE UNIT, NO AUDIO WAS OBSERVED AND ISOLATED TO A FAULTY SPEAKER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1