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

Catalog Number	KIT10001
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical was made aware of the damaged tech hub on 16-nov-2025, however was notified of the elopement on 17-nov-2025.Sensory medical advised the family to discontinue use of the bed until damaged components are replaced and properly installed.Sensory medical sent a replacement tech hub casing, tech hub hardware and cloth cover as a result of the follow up conversation in november 2025.Sensory medical has requested a return of the damaged components 24-nov-2025.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 parent described the event as her son applying excessive force to the tech hub from the inside and kicking out the screws.Once the screws were removed, the child was able to loosen the tech hub and push it out of the canopy.The parent confirmed that the child was able to elope through the tech hub portal hole as a result of the damage to the tech hub.The screws and plastic are bent and they are unable to put the product back together.The parent misplaced their tech hub cloth cover, leaving a hole that the child can climb out of during bedtime.Three pictures were provided by the complainant of the damage.Images show an empty tech hub housing with multiple locations of plastic deformation.Another image shows the tech hub portal window with the black zipper piece installed and locked into place.No apparent damage is visible to the portal zippers.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; 1580 logan street; suite 500; denver CO 80203
• Manufacturer (Section G): SENSORY MEDICAL; 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: 23810334
• Report Number: 3016541541-2025-00090
• Device Sequence Number: 18475118
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/15/2025

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: 02122024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male