BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 24974359 · Received April 23, 2026

    Report

    Report Number
    3016541541-2026-00030
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 23, 2026
    Manufacturer
    SENSORY MEDICAL INC.
    Product Code
    KMI
    UDI-DI
    00860007550263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SENSORY MEDICAL PROVIDED REPLACEMENT TECH HUB COMPONENTS TO THE PARENT. SENSORY MEDICAL REQUESTED THE RETURN OF THE DAMAGED TECH HUB FOR EXAMINATION. 09242025 IS THE LOT OF THE TECH HUB. REVIEW OF MANUFACTURING RECORDS CONFIRMS ALL IN PROCESS AND FINAL INSPECTIONS WERE PERFORMED AND 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 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 REPORTED TO SENSORY MEDICAL BY A DURABLE MEDICAL EQUIPMENT (DME) REPRESENTATIVE. THE REPRESENTATIVE PROVIDED THE CONTACT INFORMATION OF THE PARENT OF THE CHILD. PER PARENT, THE CHILD WOKE UP IN THE MIDDLE OF THE NIGHT AND BROKE THE OUTER COVER OF THE TECH HUB AND THEN CHEWED THROUGH THE CORD FOR THE HUB. PER PARENT, SHE DOES NOT BELIEVE THE CHILD SWALLOWED ANY PIECES. PER PARENT, THE CHILD REMOVED THE SCREWS FROM THE HUB AFTER THE DAMAGE OCCURRED AND THEN ELOPED THROUGH THE TECH HUB PORTAL. PER PARENT, THEY HAVE DISCONTINUED USE OF THE TECH HUB. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3901 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL INC. 09242025 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown