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

Catalog Number	CB-06FS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical has followed up on april 08, 09, and 29 (phone call), 2026, requesting further information relevant to the investigation.Sensory medical requested the damaged sheet to be returned and provided a return shipping label to the customer.As of the writing of this report the sheet has not been returned for examination.On 250614m14 is the lot for the safety sheet.Review of manufacturing records confirm 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."openings in and between bed parts can entrap the head and the neck." 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 locks and safety sheets.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 explains the key safety feature of the bed.The locks are provided to secure your safety sheet to the canopy and to secure your technology hub (or cloth cover if you're not using the technology hub) to the canopy.The s-clips are included to secure the canopy door zippers closed to prevent user elopement.Page 15 assembly + care faq's includes description and use of the locks on the safety sheets and the technology hub zippers.On 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
The parent reported that her son was stimming in the bed and pulled on the sheet, causing the zipper to tear or separate at the seam.Her son was then able to elope from the bed at the area where the safety sheet zipper separated along the seam.The parent confirmed the lock was in place at the time of the event.The parent provided three photos upon request from sensory medical.Two photos show the safety sheet zipper torn along the sheet seam.One photo shows the torn zipper in the bed.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: 25084656
• Report Number: 3016541541-2026-00036
• Device Sequence Number: 10532499
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/05/2026

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: 250710M10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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