BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23881723 · Received December 23, 2025

    Report

    Report Number
    3016541541-2025-00093
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL WAS MADE AWARE OF THE DAMAGED SAFETY SHEET ON 24-NOV-2025, HOWEVER BECAME AWARE OF THE REPORTABLE NATURE OF THE EVENT ON 10-DEC-2025. SENSORY MEDICAL HAS FOLLOWED UP THROUGH EMAIL ON 25-NOV-2025, 01-DEC-2025, 03-DEC-2025, 05-DEC-2025, 09-DEC-2025, AND 10-DEC-2025. SENSORY MEDICAL ADVISED THE COMPLAINANT TO DISCONTINUE USE OF THE DAMAGED SHEET. SENSORY MEDICAL PROVIDED REPLACEMENT SAFETY SHEETS TO THE COMPLAINANT. THE SAFETY SHEET LOT NUMBER IS 231123M13. THE MANUFACTURING RECORDS WERE REVIEWED. ALL REQUIRED INSPECTIONS WERE PERFORMED AND THERE WERE ZERO NONCONFORMANCES IN THE DHR. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ELOPEMENT AND OTHER SAFETY CONCERNS. PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR ENTRAPMENT HAZARD. "OPENINGS IN AND BETWEEN BED PARTS CAN ENTRAP THE HEAD AND THE NECK." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR ENTRAPMENT HAZARD. "TO AVOID DANGEROUS GAPS DO NOT USE THIS PRODUCT WITHOUT THE SAFETY SHEETS COMPLETELY ZIPPED AND LOCKED IN PLACE TO THE SIDEWALL. SAFETY SHEET WITH LOCK IN PLACE IS ALWAYS REQUIRED." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "USE THE MAINTENANCE CHECKLIST IN THE MANUAL TO INSPECT THE CANOPY, SEAMS, ZIPPERS, ELECTRONIC ACCESSORIES, CORDS, METAL FRAME, SCREWS, SLATS, LOCKS, AND SAFETY SHEETS EVERY 30 DAYS." PAGE 3 OF THE CUBBY BED USER MANUAL CONTAINS A WARNING FOR "IF ANY DAMAGE IS PRESENT, IMMEDIATELY DISCONTINUE USE AND CONTACT CUBBY FOR REPAIR OR REPLACEMENT." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE LOCKS AND SAFETY SHEETS. PAGE 11 INSTRUCTS TO SECURE THE SAFETY SHEET ZIPPER TO THE LOOP ON THE CANOPY WITH THE LOCK TO PREVENT THE PATIENT USER FROM REMOVING THE SHEET. DO NOT USE THE PRODUCT WITHOUT THE SAFETY SHEETS ZIPPED AND LOCKED IN PLACE. PAGE 15 EXPLAINS THE KEY SAFETY FEATURE OF THE BED. THE LOCKS ARE PROVIDED TO SECURE YOUR SAFETY SHEET TO THE CANOPY AND TO SECURE YOUR TECHNOLOGY HUB (OR CLOTH COVER IF YOU'RE NOT USING THE TECHNOLOGY HUB) TO THE CANOPY. THE S-CLIPS ARE INCLUDED TO SECURE THE CANOPY DOOR ZIPPERS CLOSED TO PREVENT USER ELOPEMENT. PAGE 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "SAFETY SHEET FABRIC, CORD LOOP AND ZIPPERS HAVE NO TEARS, RIPS OR SNAGS AND LOCK IS SECURED." PAGE 22 OF THE USER MANUAL, MAINTENANCE CHECKLIST, DESCRIBES DISCONTINUING USE OF THE BED IF ANYTHING IS DAMAGED OR MISSING. ADDITIONAL INVESTIGATION IS NEEDED, AND SENSORY MEDICAL'S ROOT CAUSE INVESTIGATION IS ONGOING. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT ONE OF THEIR SAFETY SHEETS HAS A DAMAGED ZIPPER. THE ZIPPER CAME APART IN THE MIDDLE OF THE ZIPPER, BOTH ENDS WERE INTACT. THE CHILD WAS ABLE TO SEPARATE THE ZIPPER AT THE END OF THE BED AND CRAWL OUT WHILE THE SHEET WAS INSTALLED. THE PARENT CONFIRMED THAT THE SAFETY LOCK WAS IN PLACE AT THE TIME OF THE REPORTED EVENT. THE PARENT REPORTED THERE WAS NO VISIBLE DAMAGE TO THE ZIPPER COMPONENTS. ANOTHER SHEET IS ABLE TO BE INSTALLED, SHOWING NO DAMAGE WAS DONE TO THE CANOPY SIDE OF THE SAFETY SHEET ZIPPER. THE PARENT REPORTED THAT THE ELOPEMENT HAS ONLY OCCURRED ONCE, AS THEY DISCONTINUED USE OF THE DAMAGED SAFETY SHEET. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507687 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 231123M13 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female