BEUDAMED
    FDA Adverse Event Death Summary report: N

    OWLET BABY CARE

    MDR report key: 24621455 · Received March 17, 2026

    Report

    Report Number
    3012977166-2026-00005
    Event Type
    Death
    Date Received
    March 17, 2026
    Date of Event
    September 15, 2025
    Report Date
    March 18, 2026
    Manufacturer
    OWLET BABY CARE, INC
    Product Code
    QYU
    PMA / PMN Number
    DEN220091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OWLET CONDUCTED A COMPREHENSIVE ANALYSIS OF THE DEVICE'S HISTORICAL DATA. THE DATA CONFIRMS THAT THE DEVICE OPERATED IN STRICT ACCORDANCE WITH IT'S DESIGNED SPECIFICATIONS. SPECIFICALLY, THE DEVICE CORRECTLY TRIGGERED A YELLOW ALERT DURING THE PERIOD OF UNCLEAR READINGS, FOLLOWED BY A IMMEDIATE RED ALERT UPON THE DETECTION OF OXYGEN LEVELS WITHIN THE ESTABLISHED ALERT THRESHOLD. THERE IS NO EVIDENCE OF DEVICE MALFUNCTION, DEFICIENCY, OR LATENCY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED VIA A TIKTOK SOCIAL MEDIA VIDEO THAT HER CHILD PASSED AWAY ON (B)(6) 2025. SHE REPORTS THAT THE DEVICE PROVIDED A YELLOW ALERT WHEN SHE EXPECTED A RED ALERT, BUT THE RED ALERT WAS DELAYED UNTIL CPR WAS ALREADY IN PROGRESS. SHE STATES THAT HER CHILD WAS TAKEN TO THE HOSPITAL AND PASSED AWAY DUE TO AN UNDETECTED ARTOPULMONARY WINDOW. USER DID NOT RESPOND TO ATTEMPTS MADE TO COLLECT ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682830 OWLET BABY CARE OWLET DREAM SOCK PLUS HEALTH NOTIFICATIONS QYU OWLET BABY CARE, INC DREAM SOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Female Death