BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23549591 · Received November 13, 2025

    Report

    Report Number
    3016541541-2025-00082
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS MADE MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION TO AID IN THE INVESTIGATION ON THE FOLLOWING DATES: 10/16/2025 (PHONE CONVERSATION AND EMAIL FOLLOW UP), 10/20/2025, 10/27/2025, 11/03/2025. SENSORY MEDICAL ADVISED THE PARENT TO DISCONTINUE USE OF THE BED UNTIL RESOLUTION OF THE REPORTED ISSUE COULD BE COMPLETED. THE PARENT CONFIRMED SHE DISCONTINUED USE OF THE BED. REPLACEMENT SAFETY SHEETS WERE PROVIDED TO THE CUSTOMER. SENSORY MEDICAL REQUESTED THE DAMAGED SAFETY SHEETS TO BE RETURNED FOR EXAMINATION AND PROVIDED A PRE-PAID SHIPPING LABEL. AS OF THE WRITING OF THIS REPORT THE CUSTOMER HAD NOT RETURNED THE DAMAGED SHEETS. SENSORY MEDICAL IS UNABLE TO EXAMINE THE DAMAGED SHEET. THE LOT NUMBER IS 250514M14. THE MANUFACTURING RECORDS WERE REVIEWED. ALL REQUIRED INSPECTIONS WERE COMPLETED AND ALL ACCEPTANCE CRITERIA WERE MET. 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

    THE PARENT REPORTED THAT THE SAFETY SHEETS BECAME DAMAGED AFTER BEING PLACED ON THE BED. THE FABRIC TORE, ALLOWING HER CHILD TO GET UNDERNEATH THE SHEET AND ELOPE FROM THE BED. THE PARENT STATED THAT SHE HAD EXPERIENCED SHEET TEARING PREVIOUSLY AND WAS UNSURE WHETHER HER CHILD MAY HAVE USED A SHARP OBJECT TO CAUSE THE DAMAGE. SHE RECEIVED REPLACEMENT SHEETS THROUGH HER DME, BUT THOSE SHEETS ALSO BECAME DAMAGED -THESE ARE THE SHEETS REFERENCED IN THIS COMPLAINT. THE PARENT STATED THAT SHE MADE SURE THERE WAS NO SHARP OBJECT AVAILABLE WHEN SHE PUT ON THE REPLACEMENT SHEET, HOWEVER IT BECAME RIPPED SIMILAR TO THE PREVIOUS ISSUE. THE PARENT CONFIRMED SHE DID NOT OBSERVE ANY OTHER DAMAGE TO THE REST OF THE BED. THE PARENT CONFIRMED THAT SHE FOLLOWED THE RECOMMENDATIONS FOR CARE AND WASHING OF THE SHEETS, ENSURING THEY ARE AIR DRIED AND NOT PLACED IN A CLOTHES DRYER. THE PARENT PROVIDED A PHOTO TO SENSORY MEDICAL OF THE DAMAGED SHEET TO AID IN THE INVESTIGATION. THE PHOTO CONFIRMS THE SAFETY SHEET FABRIC IS TORN. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2140872 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 250514M14 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male