MAUDE Adverse Event Report: SENSORY MEDICAL INC. CUBBY BED; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Airway Obstruction (1699); Respiratory Arrest (4461)
Date of Event	12/12/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The manufacturer has made several attempts to gather images of the damaged product and gain access to the product itself, but has not obtained or gained access these items.Therefore, the manufacturer has been unable to confirm the reported damage generally or the nature of any damage that might have occurred to the tech hub portal zipper and/or the tech hub housing.The manufacturer is continuing to seek to have the product returned or to gain access to it for evaluation.Investigation into the event to date has included: review of the labeling that was provided to the caretakers, in this instance the parents.Review of prior communication with the family.Review of manufacturing records for the cubby bed safety bed and tech hub (with no nonconformities found).Attempts to recreate the reported causes.Gathering of further information from the complainant and local authorities.The investigative efforts thus far did not identify an area where previously established specifications and controls were inadequate nor did these efforts thus far identify a gap in current process for cubby beds quality and/or manufacturing processes.The manufacturer has taken risk control measures with the product.The bed's tech hub opening has a cover that is zipped closed when the tech hub is not installed on the bed.The zipper pull is located on the outside of the bed.A lock is provided for the opening.If the tech hub is present, it will fill the opening and be secured with a lock.The tech hub and bed are made of high quality and durable materials intended for the enclosed bed environment.Finally, product labeling carries warnings intended to specifically guard against head and neck entrapment the manufacturer's investigation is ongoing.If further information is received, a supplemental report will be submitted accordingly.The manufacturer is submitting this report 1 day later than the required 30 day window due to technical issues with the fda submission portal; those have now been resolved with fda staff.
Event or Problem Description
User reportedly became entrapped in the cubby bed's technology hub portal after reportedly damaging the technology hub's housing & the cubby bed's canopy opening.The technology hub portal zipper also reportedly separated.The reported cause of death was asphyxia due to hanging (entrapment of head and neck).Note: this event was reported to sensory medical inc.On 20 november 2023.

• Brand Name: CUBBY BED
• Common Device Name: PATIENT BED WITH CANOPY/RESTRAINTS
• Manufacturer (Section D): SENSORY MEDICAL INC.; 1580 logan st.; suite 500; denver CO 80203
• Manufacturer Contact: caleb polley ; 1580 logan street; suite 500; denver, CO 80203
• MDR Report Key: 18414161
• Report Number: 3016541541-2023-23371
• Device Sequence Number: 2678858
• Product Code: OYS
• UDI-Device Identifier: 00860007550249
• UDI-Public: 860007550249
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: CUB2
• Device Lot Number: #1417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White