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

Catalog Number	CB-01FGB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical advised the customer to discontinue use of the cubby bed until damaged components could be replaced.Sensory medical requested return for examination of the damaged canopy.The product has not been returned for evaluation as of the writing of this investigation.231109m06 is the lot for the canopy.Review of manufacturing records confirmed the lot passed all in process and final inspections.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 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.The tech hub manual provides the following information: in the warnings section on page 3: check this product for damaged hardware, loose joints, loose bolts or other fasteners, missing parts or sharp edges before and after assembly and frequently during use.Securely tighten loose bolts and other fasteners.Do not use product if any parts are missing, damaged or broken.Contact cubby for replacement parts and instructional literature if needed.Do not substitute parts.On page 19 maintenance checklist: discontinue use and contact us immediately if anything is damaged or missing.Technology hub zipper + cord loop are intact and lock is secured.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 complaint was reported to sensory medical by a durable medical equipment (dme) representative.Per representative, the tech hub portal zipper teeth on the canopy and tech hub broke during regular use.Per representative, the child eloped due to the damages.Per representative, the tech hub was installed at the time that the zipper broke, and there was no previously acknowledged damage prior to the elopement.Three (3) photos were provided that show the damage to the technology hub portal zipper.Two (2) photos show damage to the tech hub portal zipper on the canopy side.One (1) photo shows damage to the tech hub portal zipper on the tech hub side.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: 25363510
• Report Number: 3016541541-2026-00041
• Device Sequence Number: 10654567
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2026

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: 231109M06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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