BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 24960391 · Received April 22, 2026

    Report

    Report Number
    3016541541-2026-00031
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 22, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL ADVISED THE PARENT TO DISCONTINUE USE OF THE BED UNTIL RESOLUTION OF THE REPORTED EVENT COULD BE COMPLETED. SENSORY MEDICAL FOLLOWED UP ON THE FOLLOWING DATES FOR ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION: 3/23/26, 3/24/26, 3/26/26, 4/06/26. THE PRODUCT WAS UNABLE TO BE EXAMINED BY SENSORY MEDICAL BECAUSE IT WAS DISCARDED BY THE PARENT. SENSORY MEDICAL PROVIDED REPLACEMENT LOCKS TO THE PARENT. THE MANUFACTURING RECORDS WERE REVIEWED, AND ALL REQUIRED INSPECTIONS WERE COMPLETED. INSPECTIONS MET THE ACCEPTANCE CRITERIA. 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 THE PARENT, HER SON WAS KICKING THE CUBBY BED BY THE SAFETY SHEET ZIPPER AND IT RIPPED, THEN THE CHILD FELL THROUGH THE RIPPED SHEET AND BECAME STUCK UNDERNEATH THE BED. THE MOTHER INDICATED THE CHILD WAS STUCK FOR APPROXIMATELY ONE MINUTE BEFORE THE PARENT WAS ABLE TO REMOVE HIM FROM THE BED. THE PARENT CONFIRMED THAT SHE WAS NOT USING THE LOCK ON THE SAFETY SHEET AT THE TIME OF THE EVENT. THE RIPPED SHEET WAS DISCARDED BY THE PARENT. THERE WERE NO PHOTOS OF THE RIPPED SHEET PROVIDED FOR REVIEW. THE PARENT PROVIDED A PHOTO OF A SECOND SHEET, NOT INVOLVED IN THE EVENT REPORTED, SHOWING THE ZIPPER PULL TAB IS MISSING. THE PARENT EXPLAINED THE ZIPPER ON THIS SECOND SHEET IS FUNCTIONAL BUT BROKEN. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168590 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL INC. 0695320123 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male