BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 2903806 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00646
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS ISOLATED TO THE MAIN BOARD. THE UNIT IS NOT LONGER MANUFACTURED AND THE MAIN BOARD IS NO LONGER AVAILABLE. THE CUSTOMER WAS ADVISED OF THE END-OF-LIFE STATUS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT DURING SERVICING OF EQUIPMENT THAT WAS BEING STORED, THE BIOMED NOTICED THAT THERE WAS NO AUDIO ON THE PULSE OXIMETER. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049 OXIMAX N-595 PULSE OXIMETER PULE OXIMETER DPZ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1