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

Catalog Number	CB-06FS
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical has followed up via email on 05/15/2026, 05/19/2026, 05/20/2026, and by phone on 06/05/2026, to obtain additional information relevant to the investigation.Sensory medical confirmed with the parent that they have a working safety sheet for the bed.Sensory medical was informed that the damaged safety sheets were discarded and unable to be returned for examination.The lot for the safety sheet is 231126m16.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 two of their safety sheets have broken due to normal use by their child who has "strong pulling" behaviors.For one, the zipper pull was torn free of the fabric it was anchored to.On the other, the zipper detached from the bottom half that allows the zipper teeth to engage and click into place and is thereby unusable.The parent stated that their child was able to elope from the bed due to the broken safety sheet zippers.The parent stated that the two safety sheet zippers broke within a month or two of each other.The parent confirmed the padlocks were being used at the time of the event.One photo was provided to sensory medical and it shows the zipper slider came off the track / teeth tape side.There was no photo provided of the report of the zipper stop coming off 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: 25490576
• Report Number: 3016541541-2026-00047
• Device Sequence Number: 13244304
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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: 231126M16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• 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: Male