BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 22310892 · Received June 23, 2025

    Report

    Report Number
    3030187577-2025-00001
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 8, 2025
    Report Date
    May 9, 2025
    Manufacturer
    HAPPIEST BABY
    Product Code
    QTG
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS BEING REPORTED IN COMPLIANCE WITH 21 CFR 803. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY HAPPIEST BABY THAT THE DEVICE, THE COMPANY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE CONDITION DESCRIBED IN THE REPORT. IN THE REPORT THE PERSON DESCRIBED ALLEGED INSTANCES OF AN UNEXPECTED CESSATION OF THE SNOO SMART SLEEPER'S MOTION FEATURE. MOTION FUNCTIONALITY IS NOT PART OF THE FDA-AUTHORIZED INFANT SUPINE SLEEP SYSTEM, AND IT IS NOT INCLUDED IN THE DE NOVO CLASS II SNOO AUTHORIZATION. AS SUCH, COMPLAINTS RELATING TO MOTION FALL OUTSIDE THE SCOPE OF MEDICAL DEVICE REPORTING OBLIGATIONS. NEVERTHELESS, EVEN IF MOTION FUNCTIONALITY IS INTERRUPTED OR DISABLED, THE KEY SAFETY MECHANISM (SECURE ATTACHMENT OF THE BABY'S SWADDLE SACK TO THE BASSINET) REMAINS ACTIVE AND CONTINUES TO MAINTAIN THE BABY IN A SUPINE POSITION, CONSISTENT WITH THE FDA'S INDICATIONS FOR USE. IN LINE WITH ITS COMMITMENT TO SAFETY AND PERFORMANCE, HAPPIEST BABY STRONGLY ADVISES AGAINST DISASSEMBLING OR TAMPERING WITH SNOO UNITS, AS DOING SO MAY DAMAGE INTERNAL COMPONENTS, BYPASS SAFETY MECHANISMS, OR OTHERWISE COMPROMISE PRODUCT INTEGRITY. IN CONCLUSION, BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT ANY EVENT OCCURRED THAT CAUSED AN INJURY, A RISK OF INJURY, OR A FAILURE IN THE DEVICE'S CORE SAFETY FUNCTIONALITY. ACCORDINGLY, IT IS THE OPINION OF HAPPIEST BABY THAT THIS REPORT DOES NOT SUPPORT A CLAIM THAT THE SNOO SMART SLEEPER OR ITS SLEEP SACK PRESENT A PRODUCT-RELATED SAFETY RISK. FURTHERMORE, THE REPORTED ISSUE PERTAINS TO A FEATURE (MOTION FUNCTIONALITY) THAT IS UNRELATED TO THE FDA'S DE NOVO AUTHORIZED INFANT SUPINE SLEEP SYSTEM. THEREFORE, THIS REPORT FALLS OUTSIDE THE SCOPE OF MDR REPORTING REQUIREMENTS AS DEFINED BY THE FDA.

    Description of Event or Problem · 0

    A PERSON SUBMITTED A MEDWATCH REPORT SAYING THAT THE SNOO SMART SLEEPER WAS REPORTED ON SOCIAL MEDIA TO HAVE A MALFUNCTION WHERE IT SHUTS OFF UNEXPECTEDLY WITHIN MINUTES OF ACTIVATION. THE PERSON ALLEGED THAT THEY READ MANY REPORTS CLAIMING THAT THIS DISRUPTS INFANT SLEEP AND HE SAID HE HAD SAFETY CONCERNS, WHICH WERE UNSPECIFIED. THE PERSON ALSO SAID THAT THE BED'S APP MAY INACCURATELY INDICATE THAT THE UNIT IS ACTIVE - EVEN AFTER IT HAS STOPPED - OR MAY BRIEFLY DISPLAY A "CLIPS NOT ENGAGED" MESSAGE, DESPITE THE CLIPS BEING PROPERLY SECURED. NO INJURY, SPECIFIC HEALTH CONCERN OR NEED FOR MEDICAL CARE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928978 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female