MAUDE Adverse Event Report: SENSORY MEDICAL INC. CUBBY BEDS; CANOPY BED

Catalog Number	CB-01FGB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The parent reported that her child separated the safety sheet zipper and eloped through the mattress area.In addition, the parent reported that her child unzipped the safety sheet and the cloth cover of the technology hub portal and eloped from the bed.The parent confirmed that she was not using the necessary locks because she was not provided them at the installation of the bed by the provider.The parent also reported that the bed slats under the mattress are bent or broken due to the child jumping around inside the bed.She explained that she noticed the damage a couple months prior but did not report the issue, until she was having issues with the safety sheet and cloth cover zippers.There was no report of injury as a result of the event.
Additional Manufacturer Narrative
Sensory medical advised the parent to discontinue use of the bed until resolution of the issues could be completed.Sensory medical has followed up on 05/19/2026 (by email and phone), 05/20/2026 (email), 05/26/2026 (email), and 06/01/2026 (phone) to obtain additional information relevant to the investigation.The parent did not respond to the additional requests for information and did not provide requested photos.Sensory medical advised the parent to use the required locks to secure the safety sheets and the cloth cover, and provided replacement locks.The manufacturing records were reviewed.All required inspections were completed and acceptance criteria were met.The cubby bed user manual includes various directives to ensure safe operation and mitigate risks like elopement or other hazards.Entrapment hazard warnings on page 3 specify that openings within or between bed components may lead to head and neck entrapment.Page 3 also states that the product must never be used unless safety sheets are fully zipped and secured with locks to the sidewall to eliminate dangerous gaps.Instructions on page 3 mandate utilizing the maintenance checklist every 30 days to examine the canopy, zippers, slats, locks, and other hardware.Page 3 further directs that use must be stopped immediately if damage is found, followed by contacting cubby for necessary repairs.The parts inventory listed on page 5 explicitly mentions the safety sheets and the required locks.Guidance on page 11 describes locking the safety sheet zipper to the canopy loop to ensure the patient cannot detach the sheet.Key safety features detailed on page 15 include locks for the safety sheet and technology hub, plus s-clips to prevent elopement through door zippers.The assembly and care faq section on page 15 elaborates on the application of locks for the technology hub and safety sheets.The monthly maintenance checklist on page 22 requires confirming that safety sheet zippers and fabric are intact and that the lock is fastened.Finally, the maintenance section on page 22 reiterates the necessity of halting bed use if any parts are missing or compromised.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: CANOPY BED
• 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: 25538177
• Report Number: 3016541541-2026-00049
• Device Sequence Number: 15801597
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/17/2026

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: CB-01FGB
• Device Lot Number: 240717M08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male