MAUDE Adverse Event Report: SENSORY MEDICAL CUBBY BEDS; TECHNOLOGY HUB

Catalog Number	KIT10001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical made seven (7) attempts to gather additional information relevant to the investigation but was unsuccessful, as a result sensory medical was unable to confirm that chewing of cords was the result of exposure of the internal components of the tech hub.The tech hub lot number or serial number was not made available to cubby beds and therefore the manufacturing records were unable to be reviewed.A replacement tech hub was provided.Pack80029 v1.0 tech hub accessory manual includes the following warnings: pg 3 - 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.If any damage is present immediately discontinue use and contact cubby for repair or replacement.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.Periodically examine electronic accessories of this product for damage to the cord, housing or other parts that may result in the risk of fire, electric shock or injury.If the product is damaged, do not use it.Sensory medical's root cause investigation is ongoing, and the company will supplement this report as necessary.There was no report of injury as a result of the event.
Event or Problem Description
The dme representative reported that there was damage to the technology hub.The child chewed the tech hub cords for the camera and light.The zipper that goes around the tech hub was missing a few mounting screws for the zipper that mounts around the outside of it.Photos provided by the dme show that the tech hub was not installed and the cloth cover was not in place (the tech hub portal side of the bed was placed against a wall and did not have the tech hub or cloth cover installed and the wall had pieces removed / chipped out).The photos show the tech hub housing has separated and the zipper ring was partially detached confirming the dme's statement that some of the screws that mount the zipper ring were missing.Another photo confirms what appear to be chew marks on the light and camera cords.The dme reported that the child has a condition that causes him to eat non-food items.There was no injury as a result of the event.

• Brand Name: CUBBY BEDS
• Common Device Name: TECHNOLOGY HUB
• Manufacturer (Section D): SENSORY MEDICAL; 1580 logan street; suite 500; denver CO 80203
• Manufacturer (Section G): SENSORY MEDICAL; 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: 21938656
• Report Number: 3016541541-2025-00031
• Device Sequence Number: 12113628
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: KIT10001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male