BEUDAMED
    FDA Adverse Event Death Summary report: N

    RED DCI-DC3

    MDR report key: 4254624 · Received November 7, 2014

    Report

    Report Number
    2031172-2014-00396
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 10, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER THAT A PATIENT EXPIRED AND WOULD LIKE TO HAVE THE RAD-8 DEVICE EVALUATED. CUSTOMER STATED THAT SHE DID NOT KNOW WHETHER THE DEVICE WAS BEING USED. NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718494 RED DCI-DC3 OXIMETER DQA MASIMO CORPORATION 2053 14EEE

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death