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

Catalog Number	KIT10001
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical was made aware of the damaged tech hub on 11/01/2025, however was notified of the elopement through the tech hub on 02/12/2026.Sensory medical provided a return shipping label to the parent for return and examination of the damaged tech hub.Sensory medical provided a replacement cloth cover and hardware kit to the complainant.Multiple statements are made in the tech hub accessory manual regarding safe use of the bed to prevent elopement and other safety concerns.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.Additional investigation is needed, and sensory medical's root cause investigation is ongoing.
Event or Problem Description
Per parent, her son kicked the tech hub repeatedly leading to the screws breaking.Per the parent, her son was able to get out of the cubby bed even when the tech hub was zipped into the canopy and locked.Per parent, the child received small cuts on their feet that did not require medical attention.The parent provided four (4) photos that appear to confirm the damage to the tech hub.Two (2) of the photos show a disassembled tech hub that was still zipped in.There is evident damage around the screw junctions, leading to the disassembly.The other two (2) photos show damage to the camera cord.

• Brand Name: CUBBY BEDS
• Common Device Name: TECHNOLOGY HUB
• Manufacturer (Section D): SENSORY MEDICAL INC.; 1580 logan street; suite 500; denver 80203
• Manufacturer (Section G): SENSORY MEDICAL INC.; 1580 logan street; suite 500; denver CO 80203
• Manufacturer Contact: justin o'neal ; 1580 logan street; suite 500; denver, CO 80203 ; 8559642664
• MDR Report Key: 24523987
• Report Number: 3016541541-2026-00019
• Device Sequence Number: 9691629
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 11032023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2025
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: Male