BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS INF ADHESIVE SENSOR

    MDR report key: 7107674 · Received December 12, 2017

    Report

    Report Number
    7107674
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 28, 2017
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS DE-SATTING TO LOW 80'S WITH GOOD WAVE. PLACED ON OXYGEN 1L N/C WITH NO EFFECT. RAISED TO 2L WITH OXYGEN LEVEL TO LOW 90'S. CALLED MD TO ROOM TO ACCESS. RAISED OXYGEN TO 4L N/C WITH OXYGEN SATS REMAINING AT LOW 90'S. MEDICAL EMERGENCY TEAM (MET) CALLED. THEN A NEW OXYGEN PROBE WAS PLACED AND SATS INCREASED TO 100%. O2 SAT PROBE GIVEN TO NURSE MANAGER, SINCE IT LOOKED PERFECTLY FINE BUT IT WAS OBVIOUSLY NOT READING CORRECTLY. OXYGEN DC'D AND PATIENT WAS PERFECTLY FINE WITH O2 SATS AT 99-100%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886758 LNCS INF ADHESIVE SENSOR OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT KNOWN.