BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 24968795 · Received April 23, 2026

    Report

    Report Number
    3016541541-2026-00032
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 22, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    KMI
    UDI-DI
    00860007550263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS FOLLOWED UP ON THE FOLLOWING DATES TO OBTAIN ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION: 03/26/2026, 03/31/2026, 04/02/2026, 04/07/2026, 04/09/2026, 04/17/2026 (PHONE CALL ATTEMPT). SENSORY MEDICAL HAS RECEIVED NO RESPONSES OR ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. 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.

    Description of Event or Problem · 0

    THE DME REPRESENTATIVE REPORTED THAT THE CLIENT WAS ABLE TO ELOPE FROM THE BED, AND THAT THE TECHNOLOGY HUB WAS BROKE AND PINCHED THE CHILD'S HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343262 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL INC. 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male