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

Catalog Number	CB-06FS
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Abrasion (1689); Physical Entrapment (2327)
Date of Event	05/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The parent reported that her son ripped the safety sheet, crawled under the bed and became temporarily entrapped.Per parent, she noticed a small hole in the safety sheet the day prior to the event.She stated that her son was able to rip the sheet at the location of the hole.The parent stated that her son sustained a small scratch on his leg as a result of the event.
Additional Manufacturer Narrative
Sensory medical has followed up on 06/01/2026 (phone call, text messages, email).06/02/2026 (phone call, text message), 06/04/2026 (text message), and 6/12/2026 (text message) to gather information relevant to the investigation.Sensory medical provided replacements for the safety sheet, padlocks, and s-clips to the customer.Sensory medical advised the customer to discontinue use of the bed until a resolution of the issue can be completed.The parent confirmed that she discarded the damaged sheets.Additional information obtained from the customer confirms that the required padlocks were not being used to secure the safety sheet.The parent stated that she did not remember receiving the padlocks, and instead was using the s-clips to secure the safety sheet.Sensory medical explained to the customer the proper use of the padlocks and s-clips, including sending written instructions with photos.The parent confirmed that she received the replacement sheet and has no additional concerns.The manufacturing records were reviewed as part of the investigation.All required inspections were performed and passed the acceptance criteria.Multiple statements are made in the cubby bed user manual regarding safe use of the bed to prevent elopement and other safety concerns.Page 3 of the cubby bed user manual contains a warning for entrapment hazard."to avoid dangerous gaps do not use this product without the safety sheets completely zipped and locked in place to the sidewall.Safety sheet with lock in place is always required."" page 3 of the cubby bed user manual contains a warning for ""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."" page 3 of the cubby bed user manual contains a warning for ""if any damage is present, immediately discontinue use and contact cubby for repair or replacement."" page 5 contains a parts list, which includes the safety sheets and locks.Page 11 instructs to secure the safety sheet zipper to the loop on the canopy with the lock to prevent the patient user from removing the sheet.Do not use the product without the safety sheets zipped and locked in place.On page 15 "what happens if my cubby rips or i notice other damage? please contact us right away.Only use your cubby bed when it is assembled correctly and is in safe working condition" page 15 assembly + care faq's includes description and use of the locks on the safety sheets and the technology hub zippers.Page 22 includes a monthly maintenance checklist, one check is: "safety sheet fabric, cord loop and zippers have no tears, rips or snags and lock is secured." on page 22 includes a monthly maintenance checklist, one check is: "each zipper on the canopy is functional and seams of zippers are intact." page 22 of the user manual, maintenance checklist, describes discontinuing use of the bed if anything is damaged or missing.Additional investigation is needed, and sensory medical's root cause investigation is ongoing.

• 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: 25630031
• Report Number: 3016541541-2026-00052
• Device Sequence Number: 9728718
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/25/2026

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-06FS
• Device Lot Number: 0713930623
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male