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	04/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Per complainant, her son damaged his technology hub while enclosed in his bed by chewing the face plate and chewing apart a few of the wires and she noticed the damage a few days before contacting sensory medical.Complainant stated the tech hub has been replaced with the cloth portal cover in the bed.Per complainant, the child is not injured.A picture shows a crack in the bottom right internal corner of the tech hub housing assembly.Another picture shows the wire (likely the radio wire) the child chewed on and the control insert which was removed from the tech hub.There was no report of injury as a result of the event.
Additional Manufacturer Narrative
Sensory medical is sending replacement tech hub components.Sensory medical directed the complainant to use the portal cover while waiting for the tech hub replacement.Without the lot number, further investigation cannot be completed.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.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.

• 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: 22081434
• Report Number: 3016541541-2025-00045
• Device Sequence Number: 21207671
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/23/2025

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: 04/27/2025
• Initial Report FDA Received Date: 05/23/2025
• 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