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	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: CUBBY BEDS
• Common Device Name: TECHNOLOGY HUB
• Manufacturer (Section D): SENSORY MEDICAL INC.; 1580 logan street; suite 500; denver CO 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: 24974359
• Report Number: 3016541541-2026-00030
• Device Sequence Number: 10456190
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 09242025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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: Unknown