BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23549352 · Received November 13, 2025

    Report

    Report Number
    3016541541-2025-00081
    Event Type
    Malfunction
    Date Received
    November 13, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 13, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    KMI
    UDI-DI
    00860007550263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL ADVISED THE FAMILY TO DISCONTINUE USE OF THE BED UNTIL DAMAGED COMPONENTS ARE REPLACED. SENSORY MEDICAL IS IN THE PROCESS OF PROVIDING A REPLACEMENT TECH HUB. PER THIS INVESTIGATION, IT WAS CONFIRMED THAT THE FAMILY WAS NOT USING THE REQUIRED LOCK FOR THE TECH HUB ZIPPER. THE TECH HUB MANUAL PROVIDES THE FOLLOWING INFORMATION: IN THE WARNINGS SECTION ON PAGE 3: · 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. ON PAGE 19 MAINTENANCE CHECKLIST: · DISCONTINUE USE AND CONTACT US IMMEDIATELY IF ANYTHING IS DAMAGED OR MISSING. · TECHNOLOGY HUB ZIPPER + CORD LOOP ARE INTACT AND LOCK IS SECURED. 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 COMPLAINT WAS ORIGINALLY REPORTED BY A DURABLE MEDICAL EQUIPMENT (DME) REPRESENTATIVE. ACCORDING TO THE COMPLAINANT, THE PARENT'S DAUGHTER BENT THE PLASTIC COVERING OF THE TECH HUB, PUSHED THE TECH HUB COMPONENTS THROUGH THE PORTAL AND ELOPED FROM THE BED. THE COMPLAINANT CONFIRMED THE DAUGHTER WAS NOT INJURED. ON OCTOBER 20, 2025 THE COMPLAINANT STATED THE DAMAGE OCCURRED APPROXIMATELY 1.5 WEEKS BEFORE. THE COMPLAINANT STATED NO LOCK WAS IN USE ON THE TECH HUB. THREE PHOTOS OF THE TECH HUB WERE PROVIDED BY THE DME REPRESENTATIVE. TWO PHOTOS SHOW THE DISCONNECTED INTERNAL HOUSING PANEL WITH A TEAR AND A HOLE ON THE BOTTOM RIGHT HAND SIDE. A THIRD PICTURE SHOWS THE EXTERNAL TECH HUB HOUSING PANEL, CAMERA, AND CIRCADIAN LIGHT & SPEAKER HANGING BY THE WIRES ON THE INSIDE OF THE BED. THE TECH HUB ZIPPER PANEL WAS NOT VISIBLE IN ANY OF THE PICTURES. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977621 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL, INC. 5232024 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female