BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 25084494 · Received May 5, 2026

    Report

    Report Number
    3016541541-2026-00035
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    OYS
    UDI-DI
    00860007550249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL REQUESTED RETURN FOR EXAMINATION OF THE DAMAGED SAFETY SHEET. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AS OF THE WRITING OF THIS INVESTIGATION. 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." PAGE 5 CONTAINS A PARTS LIST, WHICH INCLUDES THE SAFETY SHEETS AND LOCKS. 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. 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 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS. 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." 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

    A COMPLAINT WAS REPORTED TO SENSORY MEDICAL BY A DURABLE MEDICAL EQUIPMENT (DME) REPRESENTATIVE. PER REPRESENTATIVE, THE CHILD BROKE THE SAFETY SHEET ZIPPER AND ELOPED THROUGH IT. PER REPRESENTATIVE, THE MOM SAID THE LOCK WAS INSTALLED AT THE TIME OF THE EVENT AND THE CHILD PULLED HARD ENOUGH TO BREAK THE ZIPPER WITH THE LOCK STILL ATTACHED. A PICTURE PROVIDED SHOWS THE UNINSTALLED SAFETY SHEET WITH A MISSING ZIPPER SLIDER, AND ANOTHER SHEET WITH A DAMAGED ZIPPER WITH FRAYING THREADS. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498712 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL INC. 231023M01 00860007550249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male