BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUBBY BEDS

    MDR report key: 23408509 · Received October 28, 2025

    Report

    Report Number
    3016541541-2025-00077
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 28, 2025
    Manufacturer
    SENSORY MEDICAL, INC.
    Product Code
    KMI
    UDI-DI
    00860007550263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER COMPLAINANT, THE BED WAS RECEIVED SECONDHAND AS A GIFT IN NOVEMBER 2024, BUT IT DID NOT COME WITH A TECH HUB, PORTAL COVER, OR LOCKS. HE PURCHASED A TECH HUB FROM SENSORY MEDICAL ON (B)(6) 2024. REVIEW OF COMMUNICATIONS IN NOVEMBER WITH THE FAMILY INDICATES THAT THE FAMILY PREVIOUSLY REQUESTED A TECH HUB COVER AND LOCKS FROM CUBBY; HOWEVER, THERE IS NO EVIDENCE THAT ANY WERE PROVIDED AT THAT TIME. THE FINAL COMMUNICATION FROM THE COMPLAINANT, DATED ON (B)(6), 2024, NOTED THAT LOCKS AND A PORTAL COVER WERE STILL NEEDED BUT COULD NOT PROVIDE EVIDENCE OF PURCHASE AS REQUIRED BY THE THEN ACTIVE SENSORY MEDICAL WARRANTY. EXAMINATION OF PAST SENSORY MEDICAL RECORDS CONFIRMS THAT NO ORDERS CONTAINING THESE ITEMS WERE ISSUED TO THE COMPLAINANT. COMPLAINANT STATED WHEN HE RECEIVED THE TECH HUB, HE ONLY RECEIVED 3 OF THE 5 SCREWS AND INSTALLED IT WITH TWO SCREWS MISSING. THE COMPLAINANT SHARED HIS SON IS NOW FORCING HIMSELF THROUGH THE TECH HUB PORTAL, IS ESCAPING THE BED AND HAS CAUSED DAMAGE TO THE TECH HUB ZIPPER AND CAMERA. COMPLAINANT SAID HE COULD NOT LOCATE THE THREE SCREWS AND HAD MISPLACED THE CONTROL INSERTS. PER COMPLAINANT, THIS DAMAGE OCCURRED ABOUT A WEEK BEFORE HE CALLED. SENSORY MEDICAL HAS FOUND NO RECORD THAT THE COMPLAINANT NOTIFIED SENSORY MEDICAL OF THE TWO MISSING TECH HUB SCREWS TO REQUEST THEIR REPLACEMENT. THREE PICTURES WERE PROVIDED THAT SHOW THE SEPARATED TECH HUB HOUSING COMPONENTS. THE TWO HOUSING COMPONENTS ARE INTACT AND A PORTION OF THE ZIPPER SEAM IS DAMAGED. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT. MANUFACTURER'S NARRATIVE: SENSORY MEDICAL HAS ADVISED THE COMPLAINANT TO DISCONTINUE USE OF THE BED. SENSORY MEDICAL SENT A REPLACEMENT CAMERA, TECH HUB CASING, TECH HUB HARDWARE AND CLOTH COVER AS A RESULT OF THE FOLLOW UP CONVERSATION ON (B)(6) 2025. SENSORY MEDICAL HAS REQUESTED A RETURN OF THE DAMAGED COMPONENTS. 08142024 IS THE LOT FOR THE TECH HUB. REVIEW OF MANUFACTURING RECORDS CONFIRMS ALL 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

    PER COMPLAINANT, THE BED WAS RECEIVED SECONDHAND AS A GIFT IN NOVEMBER 2024, BUT IT DID NOT COME WITH A TECH HUB, PORTAL COVER, OR LOCKS. HE PURCHASED A TECH HUB FROM SENSORY MEDICAL ON (B)(6) 2024. REVIEW OF COMMUNICATIONS IN NOVEMBER WITH THE FAMILY INDICATES THAT THE FAMILY PREVIOUSLY REQUESTED A TECH HUB COVER AND LOCKS FROM CUBBY; HOWEVER, THERE IS NO EVIDENCE THAT ANY WERE PROVIDED AT THAT TIME. THE FINAL COMMUNICATION FROM THE COMPLAINANT, DATED ON (B)(6) 2024, NOTED THAT LOCKS AND A PORTAL COVER WERE STILL NEEDED BUT COULD NOT PROVIDE EVIDENCE OF PURCHASE AS REQUIRED BY THE THEN ACTIVE SENSORY MEDICAL WARRANTY. EXAMINATION OF PAST SENSORY MEDICAL RECORDS CONFIRMS THAT NO ORDERS CONTAINING THESE ITEMS WERE ISSUED TO THE COMPLAINANT. COMPLAINANT STATED WHEN HE RECEIVED THE TECH HUB, HE ONLY RECEIVED 3 OF THE 5 SCREWS AND INSTALLED IT WITH TWO SCREWS MISSING. THE COMPLAINANT SHARED HIS SON IS NOW FORCING HIMSELF THROUGH THE TECH HUB PORTAL, IS ESCAPING THE BED AND HAS CAUSED DAMAGE TO THE TECH HUB ZIPPER AND CAMERA. COMPLAINANT SAID HE COULD NOT LOCATE THE THREE SCREWS AND HAD MISPLACED THE CONTROL INSERTS. PER COMPLAINANT, THIS DAMAGE OCCURRED ABOUT A WEEK BEFORE HE CALLED. SENSORY MEDICAL HAS FOUND NO RECORD THAT THE COMPLAINANT NOTIFIED SENSORY MEDICAL OF THE TWO MISSING TECH HUB SCREWS TO REQUEST THEIR REPLACEMENT. THREE PICTURES WERE PROVIDED THAT SHOW THE SEPARATED TECH HUB HOUSING COMPONENTS. THE TWO HOUSING COMPONENTS ARE INTACT AND A PORTION OF THE ZIPPER SEAM IS DAMAGED. THERE WAS NO REPORT OF INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744944 CUBBY BEDS TECHNOLOGY HUB KMI SENSORY MEDICAL, INC. 08142024 00860007550263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male