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

Catalog Number	CB-06FS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical was made aware of the damaged safety sheet zipper on 05/14/2026, however was notified of the elopement through the safety sheet on (b)(6) 2026.Sensory medical made multiple attempts to obtain additional information relevant to the reported issue and investigation on 05/20/2026 (email), 05/22/2026 (email), and 06/10/2026 (phone).Sensory medical provided a replacement safety sheet.Sensory medical requested return for examination of the damaged safety sheet.The product has not been returned for evaluation as of the writing of this investigation.231123m13 is the lot of the safety sheet.Review of manufacturing records confirms all in process and final inspections were performed and passed.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 5 contains a parts list, which includes the 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.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." 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.There was no report of injury as a result of the event.
Event or Problem Description
A complaint was reported to sensory medical by a durable medical equipment (dme) representative.Per representative, the child broke the safety sheet zipper and eloped through it.Per representative, the parents stated that the child pulled on the zipper and broke it.Two (2) pictures were provided by the representative.Both images show the side of the cubby bed without a safety sheet installed.No images were provided that show the damage to the safety sheet.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: 25488202
• Report Number: 3016541541-2026-00045
• Device Sequence Number: 9930061
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: 231123M13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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: Unknown