MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN PATIENT BREATHING PACKAGE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	PEDIATRIC, ACTIVE, HEATED, OXYGEN, BLUE
Medical Device Problem Codes	Material Separation (1562); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: ventec performed a visual inspection of the patient circuit (pediatric, active, heated, blue) where it was confirmed that the circuit bond joint separated at the active valve transducer housing to valve mount housing.Ventec's examination confirmed that adhesive was present, but ventec could not confirm whether there was adequate adhesive for proper bond strength.The circuit will be sent back to the contract manufacturer (vincent medical) for further evaluation.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Event or Problem Description
It was reported to ventec that a patient circuit (pediatric, active, heated, blue) broke at the exhalation valve.The reporter also stated that the device had displayed a patient circuit disconnect alarm, which may have been due to the broken circuit.There was patient involvement associated with the reported event, however, there were no reports of patient harm as a result of the reported issue.

• Brand Name: VOCSN PATIENT BREATHING PACKAGE
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer (Section G): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 23287560
• Report Number: 3013095415-2025-00892
• Device Sequence Number: 21046371
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: Health Professional
• Device Model Number: PEDIATRIC, ACTIVE, HEATED, OXYGEN, BLUE
• Device Catalogue Number: PRT-00806-002
• Device Lot Number: 232601
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Sex: Female
• Patient Race: Asian