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)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical is working with the dme to send a replacement tech hub and canopy.Sensory medical directed the complainant to discontinue use of the bed until replacements are installed.The lot number for the tech hub is 11122024.The lot records were reviewed and the lot passed all inspections.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.Sensory medical's root cause investigation is ongoing, and the company will supplement this report as necessary.There was no report of injury as a result of the event.
Event or Problem Description
Per complainant, a dme representative, the child cracked and pushed out the tech hub then proceeded to climb through the tech hub hole, climb to the top of the bed and jump on the top of the canopy leading to a tear the roof and the child falling through.Per complainant, no injuries were reported.Two pictures were provided that show torn fabric along the edge of the roof.A picture shows the tech hub portal where the zipper pull tab and locking loop are locked to the padlock, but the pull tab (tab where zipper is pulled by the user) is disconnected from the slider (component the moves along the zipper teeth) and there is no tech hub in the portal.Two pictures show the tech hub, which is not attached to the bed, with a crack in the bottom left internal corner of the housing and the two sides of the housing are separated.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: 22108509
• Report Number: 3016541541-2025-00047
• Device Sequence Number: 12543332
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/29/2025

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: 11122024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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 Age: 4 YR
• Patient Sex: Unknown