BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8 HORIZONTAL

    MDR report key: 4950067 · Received July 24, 2015

    Report

    Report Number
    2031172-2015-00968
    Event Type
    Death
    Date Received
    July 24, 2015
    Date of Event
    June 25, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PRODUCTS IS RETURNED FOR EVALUATION OR NEW INFO IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED ASSISTANCE IN DOWNLOADING THE TREND ON RAD-8 THAT MIGHT HAVE BEEN IN USE ON A HOMECARE PT AT THE TIME OF DEATH. ADDITIONAL INFO RECEIVED INDICATED THERE WAS NEVER A PROBLEM WITH THE OXIMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482221 RAD-8 HORIZONTAL OXIMETER DQA MASIMO CORPORATION 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 Death