MAUDE Adverse Event Report: SENSORY MEDICAL, INC. CUBBY BEDS; TECHNOLOGY HUB

Catalog Number	KIT10001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CUBBY BEDS
• Common Device Name: TECHNOLOGY HUB
• Manufacturer (Section D): SENSORY MEDICAL, INC.; 1580 logan str; suite 500; denver CO 80203
• Manufacturer (Section G): SENSORY MEDICAL, INC.; 1580 logan str; suite 500; denver CO 80203
• Manufacturer Contact: justin o'neal ; 1580 logan street; suite 500; denver, CO 80203 ; 8559642664
• MDR Report Key: 23549352
• Report Number: 3016541541-2025-00081
• Device Sequence Number: 21163960
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: KIT10001
• Device Lot Number: 5232024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female