BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASIMO SENSOR

    MDR report key: 4397903 · Received December 31, 2014

    Report

    Report Number
    2031172-2014-00601
    Event Type
    Death
    Date Received
    December 31, 2014
    Date of Event
    November 28, 2014
    Report Date
    December 2, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADDITIONAL INFO REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE SENSOR USED FOR THIS EVENT WAS DISCARDED AND THE SENSOR LOT INFO WAS NOT AVAILABLE. IF NEW INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PT'S MASIMO FINGER PROBE WAS READING 95%. AN ABG WAS TAKEN AND THE FOLLOWING ARE THE TEST RESULTS: PH: 7.36, PCO2: 48, PO2: 41, HCO3: 27, SAO2: 73.9, O2HB: 74.3. THE PT WAS ON A VENTILATOR WITH TV: 500, RR: 20, PEEP: 15, FIO2: 100%. AFTER GASES WERE DONE, PEEP WAS INCREASED TO 17. ADDITIONAL INFO RECEIVED INDICATED THAT THE PT WAS A (B)(6) YEAR OLD MALE WHO WEIGHED (B)(6). AN UNKNOWN MASIMO SENSOR AND CABLE WAS USED. (B)(4) WAS NOT ON SITE WHEN THE REPORTED EVENT OCCURRED, AND THE PRODUCT WAS NOT SAVED. A PHILIPS MONITOR WITH A MMS MODULE WAS USED. THE PT'S PRE-EXISTING CONDITIONS INCLUDED SEVERE EPIGASTRIC PAIN, HYPERTENSION, AND CORONARY ARTERY DISEASE. THE REPORTED INACCURATE READINGS OCCURRED ON (B)(6) 2014 AND THE PT PASSED AWAY IN THE ICU ON (B)(6) 2014. MASIMO PRODUCT WAS IN USE ON THE PT WHEN HE PASSED AWAY, AND MEDICAL INTERVENTION INCLUDING INCREASING THE PEEP TO 17 WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863069 MASIMO SENSOR OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death