BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 5225127 · Received November 16, 2015

    Report

    Report Number
    2031172-2015-01308
    Event Type
    Death
    Date Received
    November 16, 2015
    Date of Event
    July 29, 2015
    Report Date
    October 22, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    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 EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED AN OPINION ON THE DATA DOWNLOAD RESULTS FROM A RAD-8 SN (B)(4). THE CUSTOMER REPORTED THAT THE DOWNLOAD OF THE RAD-8 WAS PERFORMED BY QUALITY MEDICAL GROUP, (B)(4). A PATIENT ON THE RAD-8 EXPIRED BETWEEN (B)(6)-2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756489 RAD-8 OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death