BEUDAMED
    FDA Adverse Event Death Summary report: N

    OWLET BABY CARE

    MDR report key: 23526287 · Received November 11, 2025

    Report

    Report Number
    3012977166-2025-00003
    Event Type
    Death
    Date Received
    November 11, 2025
    Date of Event
    September 20, 2025
    Report Date
    November 12, 2025
    Manufacturer
    OWLET BABY CARE, INC
    Product Code
    QYU
    PMA / PMN Number
    DEN220091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LOST POWER, AND THE BACKUP BATTERY OPERATED AS INTENDED. THE CUSTOMER RECEIVED A "LOST BASE STATION POWER" ALERT VIA AN AUDIBLE AND VISUAL NOTIFICATION TO THEIR BASE STATION AND MOBILE APPLICATION. DURING THE INVESTIGATION, HISTORICAL DATA LOGS CONFIRMED THAT THE MOBILE APPLICATION WAS OPENED AND ACKNOWLEDGED AFTER THE ALERTS WERE SENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THEIR CHILD PASSED AWAY THE NIGHT OF (B)(6). CUSTOMER STATES THAT AROUND 2AM, HER DEVICE STOPPED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645059 OWLET BABY CARE OWLET DREAM SOCK PLUS HEALTH NOTIFICATIONS QYU OWLET BABY CARE, INC DREAM SOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male Death