BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1512447 · Received October 14, 2009

    Report

    Report Number
    2936999-2009-00721
    Event Type
    Malfunction
    Date Received
    October 14, 2009
    Date of Event
    July 1, 2009
    Report Date
    September 17, 2009
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 09/17/2009, THE DEVICE ASSOCIATED TO THIS REPORT WAS TESTED BY THE SERVICE SITE AND NO AUDIBLE TONE WAS OBSERVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1