BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 4259034 · Received November 14, 2014

    Report

    Report Number
    2031172-2014-00414
    Event Type
    Death
    Date Received
    November 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 MALE INFANT PATIENT PASSED AWAY. PER CUSTOMER'S NOTIFICATION, THE SLEEP APNEA MONITOR (SMART MONITOR 2) AND MASIMO RAD-8 DEVICE WERE IN USE DURING THE EVENT. ADDITIONAL INFORMATION WS NO PROVIDED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738781 RAD-8 OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PHILIPS RESPIRONICS SMART MONITOR 2