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	Physical Entrapment (2327)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The parent reported that the zipper on the technology hub became partially separated and her child got her head stuck between the canopy and the tech hub assembly.The parent reported that they broke the tech hub front housing in order to free the child's head.There were three (3) photos provided by the parent.The photos confirm that the tech hub zipper was partially separated, and the front housing plate was cracked and broken off.The photos do not show or confirm if there was damage to the tech hub zipper.The parent was instructed to remove the tech hub and replace with the cloth cover.The parent reported that there have been no further issues since the cloth cover was installed.There was no serious injury as a result of the event.
Additional Manufacturer Narrative
Sensory medical is providing a replacement product.Sensory medical advised the complainant to remove the tech hub and replace with the cloth cover, which the parent confirmed had been replaced.Review of the manufacturing records for lot 240102m01 for the canopy concludes that all required product inspections were completed and passed the acceptance criteria.Sensory medical made five (5) good faith efforts to obtain additional information relevant to the investigation, but was unsuccessful in obtaining details that could facilitate the investigation.Multiple statements are made in the cubby bed user manual regarding safe use of the bed to prevent entrapment and other safety concerns.Do not allow anyone to climb or hang from the product.Do not allow anyone to jump on or against the product.You are responsible for providing adult supervision when using this product.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.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.Never leave patient user unattended for extended periods of time without monitoring and sensory stimulation.Sensory medical's root cause investigation is ongoing, and the company will supplement this report as necessary.There was no report of serious 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: 22440081
• Report Number: 3016541541-2025-00052
• Device Sequence Number: 14629889
• 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): 07/08/2025

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: 12182023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female