BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUBBY BEDS

    MDR report key: 23213890 · Received October 3, 2025

    Report

    Report Number
    3016541541-2021-00001
    Event Type
    Death
    Date Received
    October 3, 2025
    Date of Event
    June 15, 2021
    Report Date
    November 3, 2021
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    Removal / Correction Number
    Z-0918-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    11. ADDITIONAL MANUFACTURER NARRATIVE. THE ENCLOSED CANOPY BED IS DESIGNED TO MEET FDA'S 7 ZONES OF ENTRAPMENT GUIDELINES FOR HOSPITAL BEDS WHEN USED PROPERLY. THE COMPANY'S RISK ASSESSMENT HAD IDENTIFIED ENTRAPMENT AS A RISK, WHICH IS MITIGATED BY THE LOCKING OF THE BED SHEET ZIPPER (WHICH PREVENTS ACCESS TO THE SPACES BETWEEN THE MATTRESS AND BED CANOPY) AND BY THE LABELING STATEMENT IN THE ORIGINAL LABELING. THE ZIPPER ON THE BED SHEET WAS UNZIPPED TO A CERTAIN EXTENT, WHICH INDICATES THAT THE ZIPPER WAS NOT LOCKED IN PLACE TO THE CANOPY LOOP. LOCKING THE ZIPPER IN PLACE PREVENTS THE ZIPPER FROM UNZIPPING OR BEING UNZIPPED WHICH IN TURN PREVENTS ACCESS TO POTENTIAL ENTRAPMENT GAPS. THE ORIGINAL PRODUCT LABELING INSTRUCTED TO "SECURE THE SHEET ZIPPER TO THE LOOP ON THE CANOPY WITH THE #22 LOCK TO PREVENT YOUR LOVED ONE FROM REMOVING IT." THE REPORTED EVENT OCCURRED ON (B)(6) 2021 AND WAS ADDRESSED THROUGH THE SENSORY MEDICAL'S ESTABLISHED INVESTIGATION PROCEDURES AT THE TIME OF OCCURRENCE. PER THOSE PROCEDURES, SENSORY MEDICAL ATTEMPTED, MULTIPLE TIMES, TO GATHER ADDITIONAL INFORMATION. DESPITE THESE ATTEMPTS, THE CHILD'S PARENTS DECLINED TO SPEAK TO THE COMPANY, AND THE ENCLOSED CANOPY BED WAS NOT RETURNED. THE CORONER ALSO DECLINED TO SUPPLY ADDITIONAL INFORMATION, CITING HIPAA CONCERNS. THE FIRST RESPONDERS ALSO DECLINED TO PROVIDE ADDITIONAL INFORMATION. REQUESTED PHOTOS OF THE PRODUCT UNIT WERE NOT PROVIDED. ALL AVAILABLE INFORMATION ON THE EVENT CAME FROM THE MEDWATCH REPORT (MW5103228) AND THE FOLLOW-UP DISCUSSION WITH THE PARENTS' ATTORNEY. FOLLOWING THE INVESTIGATION, A VOLUNTARY ACTION WAS TAKEN TO HIGHLIGHT IN THE PRODUCT LABELING THE IMPORTANCE OF THE ORIGINAL LABELING'S INSTRUCTION TO SECURE THE SHEET ZIPPER WITH A LOCK TO PREVENT ACCESS TO THE SPACES BETWEEN THE MATTRESS AND BED CANOPY. SENSORY MEDICAL INC. HAD MULTIPLE ISSUES IN ATTEMPTING TO FILE THIS MDR IN A TIMELY FASHION, INCLUDING 30+ TICKETS WITH THE FDA HELP DESK TRYING TO SUBMIT VIA THE AGENCY'S SOFTWARE. FDA INFORMED THE SENSORY MEDICAL INC TEAM TO NOTE THIS IN THE FILE ON SUBMISSION AS IT WAS READY WITHIN 30 DAYS OF RECEIVING THE MEDWATCH LETTER. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT SENSORY MEDICAL INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    ON (B)(6) 2021, (B)(6) RECEIVED A COPY OF A MEDWATCH REPORT (MW5103228) FROM FDA CONCERNING ONE OF ITS ENCLOSED CANOPY BEDS. FROM THE MEDWATCH REPORT ITSELF, IN CONJUNCTION WITH A FOLLOW-UP DISCUSSION WITH THE PARENTS' ATTORNEY, IT APPEARS THAT THE FOLLOWING EVENT OCCURRED: A FEMALE " SPECIAL NEEDS" CHILD WAS HAVING QUIET TIME IN THE ENCLOSED CANOPY BED. THE FATHER WENT TO CHECK ON THE CHILD. HE FOUND THE CHILD UNCONSCIOUS, UNRESPONSIVE AND NOT BREATHING. THE FATHER CALLED 911. HE TRIED TO RESUSCITATE THE CHILD, BUT SHE WAS PRONOUNCED DEAD AT THE HOME. ACCORDING TO THE PARENTS' ATTORNEY, THE ZIPPER ON THE BED SHEET WAS UNZIPPED TO A CERTAIN EXTENT, ALLOWING THE TORSO AND HEAD OF THE CHILD TO FALL AND BECOME TRAPPED BETWEEN THE MATTRESS AND BED COVER. THIS ENTRAPMENT WAS ALLEGED TO HAVE CAUSED THE CHILD TO SUFFOCATE. BASED ON THE PROVIDED DESCRIPTION, THE CHILD WAS BORN WITH SOME FORM OF CONGENITAL CONDITION, NON-VERBAL AND SMALL FOR HER AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236200 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Death