BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNOO SMART SLEEPER

    MDR report key: 20820745 · Received December 2, 2024

    Report

    Report Number
    3030187577-2024-00001
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 1, 2023
    Report Date
    November 25, 2024
    Manufacturer
    HAPPIEST BABY
    Product Code
    QTG
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED IN COMPLIANCE WITH 21 C.F.R. 803. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, HAPPIEST BABY, OR ITS EMPLOYEES THAT THE DEVICE, HAPPIEST BABY, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. THE SNOO SLEEP SACK AND SMART SLEEPER WERE NOT RETURNED FOR ANALYSIS. AS MENTIONED ABOVE, THE CAREGIVER WAS USING THE SNOO WITH THE OLD-STYLE SACK, WHICH IS NOT PART OF SNOO SMART SLEEPER, A DE NOVO AUTHORIZED, CLASS II MEDICAL DEVICE. WHILE THE MANUFACTURER BELIEVES THAT THE OLD-STYLE SACK IS OUT OF SCOPE FOR MEDICAL REPORTING, AS THERE WAS NO ILLNESS OR INJURY INVOLVED WITH THE EVENT, IT IS REPORTING THE EVENT IN LINE WITH ITS COMMITMENT TO INFANT SAFETY AND FULL TRANSPARENCY. BASED ON THE INFORMATION PROVIDED BY THE CAREGIVER, HAPPIEST BABY BELIEVES THAT THE EVENT THAT CAUSED THE BABY MONITOR TO GO OFF MAY HAVE BEEN A FALSE ALARM OR AN EPISODE OF CENTRAL APNEA, BUT IT SEEMS UNLIKELY THAT IT WAS CAUSED BY A SACK-RELATED PROBLEM. THE CAREGIVER STATES THAT, ALERTED BY THE BREATHING MONITOR ALARM, THEY CHECKED THE BABY AND COULD NOT SEE HER CHEST MOVING - BUT DID NOT MENTION ANY OTHER CHANGES IN THE BABY'S APPEARANCE. THE PARENT DID NOT HEAR ANY BREATHING DIFFICULTIES, CRYING, COUGHING, OR CHOKING SOUNDS, AND DID NOT NOTICE ANY OTHER SYMPTOMS RELATED TO BREATHING OBSTRUCTION. WHEN THEY UNZIPPED THE SLEEP SACK AND RELEASED THE INNER BAND WHICH ROSE UP TO THE NECK LEVEL, THE BABY STARTED CRYING. THE PARENT DID NOT REPORT ANY MEASUREMENTS FROM THE BREATHING MONITOR. THE PARENT CONFIRMED THAT THEY DID NOT SEEK MEDICAL HELP AS THE BABY APPEARED TO BE ACTING NORMALLY. THE SNOO AND THE SNOO SLEEP SACK INCLUDE VARIOUS SAFETY FEATURES. FOR EXAMPLE, IF A BABY WERE TO MOVE DOWNWARD IN THE SLEEP SACK, THE SACK IS CONSTRUCTED SO THAT THE TOP OF THE SACK WOULD ALSO MOVE DOWNWARD WITH THE BABY, PREVENTING PRESSURE (OR "LOADING" FORCE) FROM BEING GENERATED ON THE BABY'S NECK. OTHER SAFETY FEATURES OF THE SACK INCLUDE BREATHABLE MESH IN THE UPPER FRONT PANEL OF THE SACK; THE INNER BAND, MADE OF SOFT STRETCHY FABRIC, GOES ALL THE WAY AROUND THE CHEST AND ARMS TO ENSURE THAT THE BAND'S OPENING IS MUCH LARGER THAN A BABY'S NECK, IN CASE A BABY IS ABLE TO MOVE IT UP; THE SACK AND BED ARE MADE WITH A LIMITED AMOUNT OF ROOM BETWEEN THE BABY'S FEET AND THE BOTTOM OF THE SACK (AND THE BED) TO SHORTEN THE DISTANCE A BABY COULD MOVE DOWNWARD, AND THUS REDUCE THE POTENTIAL OF ANY NECK PRESSURE. IT IS UNLIKELY THAT ANY POTENTIAL ACUTE BREATHING OBSTRUCTION WAS THE RESULT OF THE INNER ARM BANDS CAUSING STRANGULATION. THIS COULD ONLY OCCUR IF A TIGHT, CONSTRICTING FORCE PRESSED AGAINST THE NECK, INDENTING THE TRACHEA AND OBSTRUCTING THE PASSAGE OF AIR. THIS IS CONSIDERED TO BE UNLIKELY BECAUSE THE ARMS BANDS ARE INITIALLY WRAPPED AROUND THE BABY'S ENTIRE BACK, CHEST, AND EXTENDED ARMS, WHICH IS A CIRCUMFERENCE THAT IS 2-3 TIMES THE CIRCUMFERENCE OF A BABY'S NECK. THIS WOULD NOT BE EXPECTED TO CAUSE CONSTRICTION AND INDENTING OF THE TRACHEA. ALSO, THE INNER BANDS ARE MADE OF SOFT, STRETCHY COTTON THAT WOULD NOT BE EXPECTED TO CAUSE TRACHEAL OBSTRUCTION. LASTLY, STRANGULATION WOULD BE EXPECTED TO CAUSE A BABY TO BECOME ACUTELY AGITATED FROM THE TIGHT CONSTRICTION AROUND THE NECK AND WORSENING HYPOXIA. IN THE REPORTED CASE, NONE OF THESE FACTORS WERE PRESENT AND THE RAPID AWAKENING MADE THE EVENT MORE LIKELY TO HAVE BEEN CAUSED BY CENTRAL APNEA OR A FALSE ALARM OF THE MONITOR. HAPPIEST BABY WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A PARENT REPORTED THAT WHILE USING THE SNOO SMART SLEEPER BED, THEIR BABY SLID DOWN IN THE SNOO SLEEP SACK WHILE THE BED WAS AT A SLIGHT INCLINE. A BREATHING MONITOR ALERTED THE CAREGIVER, WHO CHECKED THE BABY AND COULD NOT SEE THE BABY'S CHEST MOVING. THE CAREGIVER UNZIPPED THE SACK, RELEASED THE INNER BAND OF THE SACK WHICH HAD SLID UP TO THE LEVEL OF THE NECK, AND AWAKENED THE BABY. THE PARENT CONFIRMED THE BABY WAS BREATHING AND THAT NO TREATMENT WAS REQUIRED, AND NO INJURY OR DEATH WAS REPORTED. THE PARENT ALSO CONFIRMED THAT THEY WERE USING THE OLD-STYLE SLEEP SACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94931 SNOO SMART SLEEPER SNOO QTG HAPPIEST BABY S1000

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female Required Intervention| L