BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23213989 · Received October 3, 2025

    Report

    Report Number
    3016541541-2025-00069
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    August 25, 2025
    Report Date
    October 3, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    OYS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL ADVISED THE COMPLAINANT TO DISCONTINUE USE OF THE BED UNTIL THE DAMAGED CANOPY HAS BEEN REPLACED. 0700590423 IS THE LOT FOR THE CANOPY. REVIEW OF MANUFACTURING RECORDS SHOW IT PASSED ALL IN PROCESS AND FINAL INSPECTIONS. 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 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.

    Description of Event or Problem · 0

    PER PARENT, HER 5-YEAR-OLD BROKE THE SAFETY SHEET ZIPPER, ALLOWING HIM TO CRAWL UNDER THE BED TO ESCAPE. THE PARENT SHARED THIS HAS HAPPENED FOUR TIMES, LOCKS WERE IN USE, AND HE HAS BRUISES FROM ESCAPING. THE PARENT REPORTED SHE FOUND DAMAGE TO THE CANOPY SIDE SAFETY SHEET ZIPPER. A PICTURE SHOWS THE BED WITHOUT THE SAFETY SHEET IN PLACE. A SECOND PICTURE SHOWS DAMAGE TO SEVERAL ZIPPER TEETH ON THE CANOPY SIDE SAFETY SHEET ZIPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904269 CUBBY BEDS CANOPY BED OYS SENSORY MEDICAL, INC. 0700590423

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male