BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23881725 · Received December 23, 2025

    Report

    Report Number
    3016541541-2025-00094
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 2, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS FOLLOWED UP ON DECEMBER 3 (TEXT), 5 (CALL AND TEXT), 9 (EMAIL), 2025 TO REQUEST ADDITIONAL INFORMATION. SENSORY MEDICAL HAS ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE DAMAGED BED. SENSORY MEDICAL HAS SENT A REPLACEMENT SHEET. THE SAFETY SHEET LOT IS 231222M16. REVIEW OF MANUFACTURING RECORDS CONFIRM ALL IN PROCESS AND FINAL INSPECTIONS WERE PERFORMED AND PASSED. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ENTRAPMENT AND OTHER SAFETY CONCERNS. 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." ON PAGE 15 "WHAT HAPPENS IF MY CUBBY RIPS OR I NOTICE OTHER DAMAGE? PLEASE CONTACT US RIGHT AWAY. ONLY USE YOUR CUBBY BED WHEN IT IS ASSEMBLED CORRECTLY AND IS IN SAFE WORKING CONDITION." ON PAGE 22 "DISCONTINUE USE AND CONTACT US IMMEDIATELY IF ANYTHING IS DAMAGED OR MISSING." 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." ON PAGE 22 INCLUDES A MONTHLY MAINTENANCE CHECKLIST, ONE CHECK IS: "EACH ZIPPER ON THE CANOPY IS FUNCTIONAL AND SEAMS OF ZIPPERS ARE INTACT." 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

    PER PARENT, THE SAFETY SHEET RIPPED WHERE IT ATTACHES TO THE ZIPPER AND HER SON BECAME ENTRAPPED IN THE BED FRAME WHEN TRYING TO ESCAPE AND APPEARS TO HAVE HAD DIFFICULTY BREATHING. NO MEDICAL ATTENTION WAS REQUIRED. THE PARENT STATED HER SON WAS NOT INJURED AND LOCKS WERE IN USE.. THE PARENT DID NOT KNOW HOW THE DAMAGE OCCURRED TO THE SAFETY SHEET. PER PARENT, THIS OCCURRED 3-4 WEEKS PRIOR TO HER CONTACT WITH SENSORY MEDICAL ON (B)(6) 2025. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507689 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 231222M16 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male