BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADICAL-7

    MDR report key: 5073459 · Received September 13, 2015

    Report

    Report Number
    2031172-2015-01077
    Event Type
    Death
    Date Received
    September 13, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 17, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K110028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT ALONG WITH ADDITIONAL INFORMATION REGARDING THE INCIDENT ENCOUNTERED AND THE PATIENT DETAILS. INFORMATION PROVIDED BY THE CUSTOMER INDICATES NO FURTHER INFORMATION ON THE INCIDENT DETAILS WILL BE PROVIDED TO MASIMO AND THE RADICAL-7 WILL NOT BE RETURNED FOR EVALUATION. AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT BEEN RECEIVED BY MASIMO TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE PRODUCT IS RETURNED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PATIENT INCIDENT WHERE "THE MONITOR DIDN'T ALARM". THE CUSTOMER DID NOT KNOW IF THAT MEANT THE RADICAL-7 WASN'T WORKING PROPERLY OR SOMEONE HAD ADJUSTED ALARM SETTINGS. THE PATIENT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604670 RADICAL-7 OXIMETER DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death