BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA-Y SENSOR

    MDR report key: 4226639 · Received November 5, 2014

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    Report

    Report Number
    2936999-2014-00962
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Report Date
    October 10, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DPZ
    PMA / PMN Number
    K944760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. PER INFORMATION PROVIDED IN THE OXIMAX DURA-Y DIRECTIONS FOR USE IN REGARDS TO POSSIBLE CAUSES FOR INACCURATE READINGS: WARNINGS: FAILURE TO APPLY THE DURA-Y SENSOR PROPERLY MAY CAUSE INCORRECT MEASUREMENTS. USING THE DURA-Y SENSOR IN THE PRESENCE OF BRIGHT LIGHTS MAY RESULT IN INACCURATE MEASUREMENTS. IN SUCH CASES, COVER THE SENSOR WITH AN OPAQUE MATERIAL. EXCESSIVE MOTION MAY COMPROMISE PERFORMANCE. IN SUCH CASES, TRY TO KEEP THE PATIENT STILL OR CHANGE THE SENSOR SITE TO ONE WITH LESS MOTION. WHEN THE SENSOR IS WRAPPED TOO TIGHTLY OR SUPPLEMENTAL TAPE IS APPLIED, VENOUS PULSATIONS MAY LEAD TO INACCURATE SATURATION MEASUREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED SENSOR SHOWED OF 56-60 % WITH A NELLCOR HANDHELD MONITOR (MODEL AND SERIAL NUMBER IS UNKNOWN). COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT, WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712133 DURA-Y SENSOR D-YS DPZ COVIDIEN D-YS 122900455X

    Patients

    Seq Age Sex Outcome Treatment
    1