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

Catalog Number	CB-06FS
Medical Device Problem Codes	Material Separation (1562); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Physical Entrapment (2327)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint was reported to sensory medical by a durable medical equipment (dme) representative.Per the representative, the child ripped one of the sheets on the long side near where the zipper starts and ends then became entrapped between the mattress and the frame during an attempt to escape.Per the representative, the child was able to pull on a loose thread and cause the rip.Per the representative, they do not think it was because of a manufacturing defect, and the parent was aware of the thread before elopement occurred.There was no report of injury as a result of the event.
Additional Manufacturer Narrative
Sensory medical was made aware of the damaged safety sheet on (b)(6) 2026, however was notified of the elopement on (b)(6) 2026.Sensory medical provided a return shipping label to the parent for return and examination of the damaged safety sheet.(b)(4) 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: 24630520
• Report Number: 3016541541-2026-00023
• Device Sequence Number: 21065910
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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: 240916M26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2024
• 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