BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASIMO SENSOR

    MDR report key: 4340022 · Received December 5, 2014

    Report

    Report Number
    2031172-2014-00500
    Event Type
    Death
    Date Received
    December 5, 2014
    Date of Event
    October 30, 2014
    Report Date
    November 5, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K051212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVAL OR NEW INFO IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RAPID RESPONSE TEAM WAS CALLED FOR A PT WHO WAS FOUND WITH AN O2 SAT READING OF 80%, SHALLOW BREATHING, CYANOTIC, AND GREYISH IN COLOR. THE PT WAS HYPOTENSIVE AND WHEN THE RESPIRATORY THERAPIST ARRIVED THE PT WAS ON A NON-REBREATHER MASK. SEVERAL ATTEMPTS WERE MADE TO REPOSITION SENSOR AND/OR PLACE NEW SENSOR TO SEE IF A BETTER SATURATION READING COULD BE ATTAINED. A SATURATION OF 95% WAS ATTAINED. THE RESPIRATORY THERAPIST WAS UNABLE TO OBTAIN AN ABG. IT WAS NOTICED THAT NO MATTER WHAT SATURATION WAS READING THE PLETH WAVEFORM NEVER CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786159 MASIMO SENSOR OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PHILIPS TELEPACK| PHILIPS FAST SPO2