BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 4693906 · Received April 10, 2015

    Report

    Report Number
    2031172-2015-00647
    Event Type
    Death
    Date Received
    April 10, 2015
    Date of Event
    January 30, 2015
    Report Date
    March 13, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) REQUESTED FOR MASIMO TO DOWNLOAD THE TREND DATA FROM A RAD-8 THAT WAS USED BY ONE OF THEIR CUSTOMER,S THE PATIENT ((B)(6) MALE) PASSED AWAY BACK ON (B)(6) 2015. (B)(6) STATED THAT HE HAD NO COMPLAINT REGARDING THE FUNCTIONALITY OF THE RAD-8 AND HE STATED THAT (B)(6) CUSTOMER ALSO DID NOT HAVE ANY COMPLAINTS REGARDING TH FUNCTIONALITY OF THE RAD-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238850 RAD-8 OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death