BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1733197 · Received June 14, 2010

    Report

    Report Number
    2936999-2010-00957
    Event Type
    Malfunction
    Date Received
    June 14, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 20, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON 05/20/2010, NEW INFORMATION WAS RECEIVED FROM SERVICE SITE INDICATING THAT DURING REPAIR OF THE UNIT, NO AUDIO WAS OBSERVED AND ISOLATED TO THE MAIN PCB.

    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