BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAINBOW DCI-DC3

    MDR report key: 4713000 · Received April 15, 2015

    Report

    Report Number
    2031172-2015-00656
    Event Type
    Death
    Date Received
    April 15, 2015
    Date of Event
    March 16, 2015
    Report Date
    March 16, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFO WERE MADE. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE PRODUCT IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT OBTAIN A SPCO READING. CUSTOMER REPORTED THAT BECAUSE SPCO WINDOW ON THE NON-MASIMO MONITOR THAT WAS USED WITH THE DEVICE, IS NOT VISIBLE, ONE MUST DIAL IN TO SEE WHAT THE READING IS. IT WAS REPORTED THAT THE ONLY TIME THE SPCO READY BECOME READILY AVAILABLE (ON SCREEN) IS WHEN THERE IS A READING OF 10 OR HIGHER CUSTOMER REPORTED THAT SINCE THERE WAS NO ALARM WHEN THE SPCO DOES NOT GET A READING, UNLIKE THE SPO2, WHICH DOES ALARMS WHEN IT DOES NOT GET A READING, THE MEDICS WERE NEVER AWARE THE SPCO WAS NOT OBTAINING A READING. EMS WAS NOT WARNED OF ANY PROBLEMS WITH SPCO. CUSTOMER REPORTED THAT THEY WERE RESPONDING TO SUSPECTED FOOD POISONING, HOWEVER, AND NEVER ACTIVELY CHECKED READINGS. IT WAS REPORTED THAT THE PARENTS AND (B)(6) SON WERE RELEASED BY HOSPITAL HAVING NOT BEEN TESTED FOR CO. TWO DAYS LATER EMS RESPONDED TO THEIR HOUSE AGAIN WHERE BOTH PARENTS HAD DIED OF CO POISONING AND THE SON SURVIVED. MEDICAL INTERVENTION ON THE PT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252741 RAINBOW DCI-DC3 OXIMETER DQA MASIMO CORPORATION 2201

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PHYSIO CONTROL LIFE PAK 15