BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUBBY BEDS

    MDR report key: 23185703 · Received September 30, 2025

    Report

    Report Number
    3016541541-2025-00067
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL HAS DIRECTED THE PARENT TO DISCONTINUE USE OF THE BED UNTIL REPLACEMENTS TO THE DAMAGED PARTS ARE RECEIVED. THE LOT FOR THE CANOPY IS 230901M01. REVIEW OF MANUFACTURING RECORDS CONFIRMED ALL IN PROCESS AND FINAL INSPECTIONS PASSED. 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 3 WARNINGS - ELECTRONIC ACCESSORIES: BLACK SCREWS ARE TIGHTENED ON THE BACK OF THE TECHNOLOGY HUB 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.

    Additional Manufacturer Narrative · 0

    UPDATE: RETURNED PRODUCTS TECH HUB LOT 08182023 AND CANOPY 230901M01 WERE RECEIVED ON (B)(6) 2025. THE PRODUCTS WERE INVESTIGATED ON (B)(6) 2025. REVIEW OF THE TECH HUB CONFIRMED THE LOWER THIRD OF THE HOUSING COVER IS ATTACHED, THE CAMERA IS MISSING AND THAT THE INTERNAL SIDE OF THE UPPER THIRD OF THE HOUSING COVER AND ONE OF THE SCREW HOLES HAS BEEN TORN OFF. THE LOCKING LOOP HAS WEAR AND HAS BEEN STRETCHED SHOWING EVIDENCE OF FORCE BEING APPLIED OUTSIDE OF THE BED. IN ADDITION, THERE WAS EVIDENCE OF EXCESSIVE FORCE BEING USED TO PULL OFF THE FRONT OF THE HOUSING DUE TO SCREWS BEING PULLED OUT OF SCREW HOLES. THE BLACK ZIPPER PIECE OF THE TECH HUB WAS ABLE TO BE INSTALLED ONTO THE CANOPY PORTAL WINDOW. FORCES WERE APPLIED TO ATTEMPT ZIPPER SEPARATION, BUT THE ISSUE WAS NOT ABLE TO BE REPLICATED. THE COMPLAINANT WAS EDUCATED ON CORRECT USE OF LOCKS.

    Description of Event or Problem · 0

    PER PARENT, CHILD DAMAGED TECH HUB HOUSING AND ZIPPER, ESCAPING OUT THE HOLE AND FALLING ON THE TECH HUB BREAKING HIS ARM. THE PARENT STATES THAT HER SON'S BROKEN ARM WILL REQUIRE SURGERY. THE PARENT SHARED THAT HER SON HAD PREVIOUSLY ESCAPED MULTIPLE TIMES WHEN THEY WERE NOT USING THE LOCKS, BUT HE QUIT BEING ABLE TO ESCAPE ONCE THEY STARTED USING THE LOCKS UNTIL THIS INCIDENT. PARENT STATED SHE WASN'T AWARE OF ANY PREVIOUS DAMAGE, BUT NOW THE CLOTH COVER IS NOT ZIPPING ON FULLY AND THE ELECTRONICS ARE NOT WORKING. PARENT SAYS SHE HAS NO VIDEO AVAILABLE AS THE CAMERA STATED IT WAS DISCONNECTED AT THE TIME OF THE EVENT AND THAT SHE THINKS IT MAY HAVE BEEN DAMAGED BECAUSE SHE HADN'T RECEIVED A MOVEMENT NOTIFICATION SINCE BEFORE SHE PUT HER SON TO BED THE EVENING BEFORE THE INCIDENT. A PICTURE OF THE TECH HUB SHOWS ONLY THE LOWER THIRD OF THE HOUSING COVER INTERNAL TO THE BED IS STILL ATTACHED AND THE CAMERA IS MISSING. A SECOND PICTURE SHOWS THE INTERNAL SIDE OF THE UPPER THIRD OF THE HOUSING COVER AND ONE OF THE SCREW HOLES HAS BEEN TORN OFF. A PICTURE OF THE PORTAL OPENING IN WHICH THE COMPLAINANT CLAIMED IS HOW SHE FOUND IT AFTER THE INCIDENT SHOWS THE ZIPPER FULLY UNZIPPED AT THE BASE AND THE LOCK ATTACHED TO THE ZIPPER PULL BUT NOT THE LOCKING LOOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105407 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL, INC. 08182023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R