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

Catalog Number	CB-01FGB
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per parent, the canopy separated at the seam where the zipper holds the canopy to the safety sheet.Per parent, her daughter eloped through the damaged seam and out through the bottom of the bed.Per parent, she did not notice the seam separation near the zipper until after her daughter escaped.One (1) video was provided showing the damage to the canopy.The video showed a tear in the seam between the canopy and the canopy side safety sheet zipper approximately 10 inches long.There was no report of injury as a result of the event.
Additional Manufacturer Narrative
Sensory medical was made aware of the damaged canopy side safety sheet on 04/03/2026, however was notified of the elopement through the canopy side safety sheet on 04/06/2026.Sensory medical has followed up with the parent on (b)(6) via email and april 28th via phone requesting further information.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.230828m10 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 entrapment and other safety concerns.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." 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." on page 22 "discontinue use and contact us immediately if anything is damaged or missing." 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." on page 22 includes a monthly maintenance checklist, one check is: "each zipper on the canopy is functional and seams of zippers are intact." on page 23 instructions for safety sheet care advise the user to "hang to dry" the safety sheets.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: 25060805
• Report Number: 3016541541-2026-00034
• Device Sequence Number: 21157295
• 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
• 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): 05/01/2026

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: 230828M10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2023
• 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: Female