BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 24477156 · Received February 27, 2026

    Report

    Report Number
    3030187577-2026-00002
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 20, 2026
    Manufacturer
    HAPPIEST BABY
    Product Code
    QTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF AVAILABLE MANUFACTURING AND QUALITY RECORDS WAS COMPLETED. THE DEVICE HISTORY RECORD INDICATED THE UNIT PASSED FINAL ACCEPTANCE TESTING AND WAS RELEASED, AND NO ASSOCIATED NONCONFORMANCES, DEVIATIONS, OR REWORK WERE IDENTIFIED AT THE TIME OF REVIEW. ADDITIONAL INFORMATION REGARDING THE EVENT CIRCUMSTANCES (INCLUDING SETUP AND IFU CONFORMANCE) WAS REQUESTED; HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE PRODUCT RETURN IS IN PROCESS, AND THE UNIT HAS NOT YET BEEN RECEIVED FOR EVALUATION. UPON RECEIPT, THE UNIT WILL BE INSPECTED AND FUNCTIONALLY EVALUATED WITH EMPHASIS ON THE SAFETY CLIP SYSTEM AND RETENTION PERFORMANCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. IT IS IMPORTANT TO NOTE THAT IF THE BED WAS MOVING, IT MEANS THE BABY WAS SECURELY WRAPPED IN THE SLEEP SACK WHICH WAS ATTACHED TO THE SAFETY CLIPS. THE BED'S MOTION CANNOT BE ACTIVATED UNLESS THE BABY IS PROPERLY SWADDLED AND THE WINGS ATTACHED ON BOTH SIDES IN LIGHT OF THIS, IF THE BABY WAS PROPERLY SECURED IT IS HIGHLY UNLIKELY THAT THE SNOO WAS MOVING AND HIGHLY UNLIKELY THAT THE SECURED BABY COULD FALL OUT.

    Description of Event or Problem · 0

    ON 01/19/2026, HAPPIEST BABY WAS NOTIFIED VIA A CUSTOMER'S REPORT OF AN ALLEGED INCIDENT INVOLVING A SNOO SMART SLEEPER. THE CONSUMER SAID THAT WHILE THE UNIT WAS OPERATING, THE UNIT UNEXPECTEDLY MOVED AND THE INFANT "FELL OUT" OF THE SNOO AND EXPERIENCED A HEAD IMPACT. THE CUSTOMER REPORTED THE INFANT WAS EVALUATED IN THE EMERGENCY ROOM AND THAT CT IMAGING WAS PERFORMED. PER THE CUSTOMER REPORT, THE CT SCAN DID NOT IDENTIFY AN INJURY (NO FRACTURE OR INTRACRANIAL BLEEDING). NO ADDITIONAL CLINICAL DETAILS OR MEDICAL DOCUMENTATION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4134 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000 2034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening