BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8, HORIZONTAL

    MDR report key: 7156091 · Received December 29, 2017

    Report

    Report Number
    2031172-2017-01112
    Event Type
    Death
    Date Received
    December 29, 2017
    Date of Event
    November 22, 2017
    Manufacturer
    MASIMO - 40 PARKER
    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

    ADDITIONAL MANUFACTURING NARRATIVE: 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

    THE CUSTOMER REPORTED A (B)(6)+YO CHILD DIED ON (B)(6) HOWEVER THE CHILD'S FAMILY NOTIFIED (B)(6) ON MONDAY (B)(6). CHILD, MALE, (B)(6)+YO, DOB (B)(6), ~(B)(6) LBS, WITH TRACH, CCHD REPAIRED, PIERRE ROBIN SYNDROME AND PEG FEEDING TUBE WAS OFF VENT DURING THE DAY AND ON AN LTV 1150 WITH A FISHER-PAYKEL MR850 HUMIDIFIER, RAD-8 AND BCI CAPNOCHECK ETCO2 AT NIGHT. I WAS TOLD THE CHILD DECANNULATED HIMSELF AND THE FAMILY STATES THE VENTILATOR FAULTED AND THERE WERE NO ALARMS FROM ANY EQUIPMENT INCLUDING THE RAD-8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934834 RAD-8, HORIZONTAL OXIMETER DQA MASIMO - 40 PARKER 22042

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death