BEUDAMED
    FDA Adverse Event Death Summary report: N

    OWLET BABY CARE

    MDR report key: 21866713 · Received April 18, 2025

    Report

    Report Number
    3012977166-2025-00001
    Event Type
    Death
    Date Received
    April 18, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 18, 2025
    Manufacturer
    OWLET BABY CARE, INC.
    Product Code
    QYU
    UDI-DI
    00810099090819
    PMA / PMN Number
    DEN220091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO ALLEGATIONS OF DEFICIENCY WERE MADE BY THE USER. HOWEVER, OWLET CONDUCTED A THOROUGH INVESTIGATION AND REVIEWED THE HISTORICAL DATA ANALYSIS AND BACKEND DATA. THE TIMELINE AND CORRESPONDING INTERACTION WITH THE DEVICE AND DEVICE FUNCTION ALIGN WITH THE CUSTOMER NARRATIVE AND INDICATE THAT THE DEVICE FUNCTIONED AS INTENDED IN ALERTING THE CUSTOMER TO A DESATURATION EVENT. NO DEVICE DEFICIENCY OR MALFUNCTION WAS IDENTIFIED DURING THE INVESTIGATION. THEREFORE, THE CONCLUSION OF THE INVESTIGATION IS THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED DEATH.

    Description of Event or Problem · 0

    OWLET WAS CONTACTED FOR A REQUEST FOR DATA REGARDING A DESATURATION NOTIFICATION. OWLET WAS INFORMED THAT THE INFANT HAD PASSED WHILE WEARING THE OWLET DREAM SOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776316 OWLET BABY CARE OWLET DREAM SOCK PLUS HEALTH NOTIFICATIONS QYU OWLET BABY CARE, INC. DREAM SOCK PLUS HEALTH NOTIFICATIONS 00810099090819

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female Death