BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23408842 · Received October 28, 2025

    Report

    Report Number
    3016541541-2025-00076
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 29, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL RECOMMENDED THE USER DISCONTINUE USE OF THE CUBBY BED UNTIL THE DAMAGED COMPONENTS ARE REPLACED. WITH NO RESPONSE FROM THE COMPLAINANT, ARRANGEMENTS FOR A REPLACEMENT AND REQUEST FOR A RETURN OF THE COMPLAINT COMPONENT CANNOT BE MADE. SENSORY MEDICAL REQUESTED PICTURES SHOWING THE DAMAGE TO THE ZIPPER BY EMAIL ON (B)(6) 2025 BUT NO RESPONSE WAS RECEIVED. ON 230823M09 IS THE LOT FOR THE CANOPY. REVIEW OF MANUFACTURING RECORDS CONFIRMS ALL INSPECTIONS WERE PERFORMED AND PASSED. 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. "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." 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." 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

    PER PARENT, THERE IS DAMAGE TO THE TEETH OF THE CANOPY SIDE SAFETY SHEET ZIPPER ON HER SON'S BED. THE PARENT STATED HER SON ESCAPED THE BED AND THERE ARE NO INJURIES. PARENT SHARED SHE HAS TWO SAFETY SHEETS BUT SINCE THE DAMAGE IS TO THE CANOPY SIDE SAFETY SHEET ZIPPER, NEITHER SHEET WILL STAY ZIPPED. SENSORY MEDICAL ASKED IF THE LOCKS WERE IN USE BUT NO REPLY WAS RECEIVED BY THE COMPLAINANT. A PICTURE WAS PROVIDED SHOWING A PORTION OF THE ZIPPER TEETH OF AN UNZIPPED SAFETY SHEET INSIDE THE BED, INCLUDING THE TAG. THE LOCKING LOOP THAT IS SUPPOSED TO BE NEXT TO THE TAG APPEARS TO BE MISSING. THE ZIPPER TEETH ON THE CANOPY SIDE WERE NOT VISIBLE WITHIN THE PICTURE. A SECOND PICTURE WAS PROVIDED SHOWING THE START OF THE CANOPY SIDE SAFETY SHEET ZIPPER BUT THE PICTURE IS BLURRY SO DAMAGE COULD NOT BE CONFIRMED. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226389 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 230823M09 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male