MAUDE Adverse Event Report: SENSORY MEDICAL 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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cubby beds made eight (8) attempts to obtain additional information but was unsuccessful in acquiring details relevant to the investigation.The mother provided a photo of the cloth cover partially attached to the canopy bed, with the lock in place to secure the zipper.The zipper appears to have been separated and was no longer zipped.Pack80029 v1.0 tech hub accessory manual includes the following warnings: pg 3 - use the maintenance checklist in the manual to inspect the canopy, seams, zippers, electronic accessories, cords, metal frame, screws, slats, locks and safety sheets every 30 days.If any damage is present immediately discontinue use and contact cubby for repair or replacement.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.Periodically examine electronic accessories of this product for damage to the cord, housing or other parts that may result in the risk of fire, electric shock or injury.If the product is damaged, do not use it.Mother eventually requested to return the bed in a follow up complaint.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
The mother reported that her son forcefully removed the tech hub assembly, and subsequently the replaced cloth cover, from the canopy bed and was able to elope.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: 21867089
• Report Number: 3016541541-2025-00028
• Device Sequence Number: 4695644
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/16/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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