BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 25164949 · Received May 13, 2026

    Report

    Report Number
    3016541541-2026-00038
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 13, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    KMI
    UDI-DI
    00860007550263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL ADVISED THE PARENT TO DISCONTINUE USE OF THE BED UNTIL THE ISSUE CAN BE RESOLVED. SENSORY MEDICAL PROVIDED A REPLACEMENT CLOTH COVER TO THE CUSTOMER. SENSORY MEDICAL PROVIDED A RETURN SHIPPING LABEL FOR RETURN OF THE DAMAGED TECHNOLOGY HUB. IT HAS NOT BEEN RECEIVED BACK FOR EXAMINATION AS OF THE WRITING OF THIS INVESTIGATION. SENSORY MEDICAL HAS FOLLOWED UP ON 04/23/2026, 04/24/2026, 04/27/2026, 04/28/2026, 05/04/2026, 05/06/2026 AND 05/08/2026, TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION. MULTIPLE STATEMENTS ARE MADE IN THE CUBBY BED USER MANUAL AND TECHNOLOGY HUB ACCESSORY MANUAL REGARDING SAFE USE OF THE BED TO PREVENT ELOPEMENT AND OTHER SAFETY CONCERNS. PAGE 3 OF THE USER MANUAL CONTAINS MULTIPLE WARNINGS, INCLUDING: "DO NOT USE THIS PRODUCT IF YOU DO NOT UNDERSTAND OR CANNOT FOLLOW THE ACCOMPANYING WARNINGS AND INSTRUCTIONS." "DO NOT ALLOW ANYONE TO CLIMB OR HANG FROM THE PRODUCT." "YOU ARE RESPONSIBLE FOR PROVIDING ADULT SUPERVISION WHILE USING THIS PRODUCT." "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." "IF ANY DAMAGE IS PRESENT, IMMEDIATELY DISCONTINUE USE AND CONTACT CUBBY FOR REPAIR OR REPLACEMENT." "CHECK THIS PRODUCT FOR DAMAGED HARDWARE, LOOSE JOINTS, LOOSE BOLTS OR OTHER FASTENERS, MISSING PARTS OR SHARP EDGES BEFORE AND AFTER ASSEMBLY AND FREQUENTLY DURING USE. SECURELY TIGHTEN LOOSE BOLTS AND OTHER FASTENERS." "DO NOT USE PRODUCT IF ANY PARTS ARE MISSING, DAMAGED OR BROKEN. CONTACT CUBBY FOR REPLACEMENT PARTS AND INSTRUCTIONAL LITERATURE IF NEEDED. DO NOT SUBSTITUTE PARTS." "NEVER LEAVE PATIENT USER UNATTENDED FOR EXTENDED PERIODS OF TIME WITHOUT MONITORING AND SENSORY STIMULATION." "OPENINGS IN AND BETWEEN BED PARTS CAN ENTRAP THE HEAD AND THE NECK." PAGE 15 ASSEMBLY + CARE FAQ'S INCLUDES DESCRIPTION AND USE OF THE LOCKS ON THE SAFETY SHEETS AND THE TECHNOLOGY HUB ZIPPERS AND S-CLIPS ON THE DOORS. 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 TO DISCONTINUE 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

    THE PARENT REPORTED THAT HER SON DAMAGED THE HOUSING OF THE TECHNOLOGY HUB, CAUSING IT TO CRACK AND SEPARATE, AND ELOPED FROM THE BED THROUGH THE PORTAL AREA. THE PARENT EXPLAINED THAT SHE IS UNAWARE OF HOW HER CHILD WAS ABLE TO BREAK THE TECHNOLOGY HUB HOUSING. SHE CONFIRMED THAT THE PADLOCK WAS INSTALLED ON THE TECHNOLOGY HUB AT THE TIME OF THE REPORTED EVENT. THE PARENT PROVIDED ONE PHOTO OF THE DAMAGED TECHNOLOGY HUB. THE PHOTO CONFIRMS THE HOUSING IS CRACKED, AND A PIECE OF THE HOUSING IS BROKE OFF FROM THE DEVICE. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37830 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL INC. 12182023 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male