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	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sensory medical has followed up requesting the order number for the tech hub to trace the lot number as the original order number supplied did not include the tech hub.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.Instructions on page 11: "zip the technology hub into the canopy and secure the zipper to the loop using the lock provided." 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.
Event or Problem Description
Per complainant, approximately two months after starting to use a tech hub, she noticed the camera was offline, went to investigate and found her child had damaged the tech hub and had his arm and head through the opening.Per parent, she did not observe that her son was hurt but stated they could not locate one of the screws.Per complainant, the screws were installed securely.The family is planning to use the cloth insert until their tech hub is replaced.A picture shows an incomplete piece of the inner housing sitting on the floor, broken at the base of the large hole.A picture shows the camera and damaged inner housing panel on the floor.A picture shows the damaged tech hub attached to the bed at the base, with the bottom portion of the inner housing panel attached, the sound machine attached, and the camera missing, and the zipper still intact and secured to the locking loop with a lock.There was no report of injury as a result of the event.
Additional Manufacturer Narrative
02172025 is the lot of the tech hub associated with this complaint.Review of the manufacturing records confirmed the lot passed all inspections.

• 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: 22188142
• Report Number: 3016541541-2025-00050
• Device Sequence Number: 21032488
• Product Code: KMI
• UDI-Device Identifier: 00860007550263
• UDI-Public: 860007550263
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 07/08/2025

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
• Device Lot Number: 02172025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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