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

Model Number	ADULT, PASSIVE, OXYGEN, BLUE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: ventec will perform an evaluation of the returned patient circuit.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 the clear film wall of a breathing circuit had detached from the blue polypropylene spiral portion of the patient circuit (adult, passive, oxygen, blue) assembly.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the contract manufacturer, vincent medical, was notified of the reported issue.The reported issue of patient circuit delamination was confirmed visually using the customer provided photo.The contract manufacturer performed an investigation and advised ventec that the relevant extrusion process had been validated and state of validation had been maintained.All associated dhrs for the part number and lot code were reviewed and they did not identify any delamination failures.Additionally, there were no deviations, ncs, or excursions from validated process.All finished goods produced from the common extrusion lot and the suspect lot relevant to the part number and lot 204804 had passed all qc testing performed during the extrusion process, sampling on the finished tubing and finished device with respect to delamination failure.No prior events of delamination during manufacturing process of ventec circuits were identified.The cause of the reported issue could not be determined.

• 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: 20208038
• Report Number: 3013095415-2024-00656
• Device Sequence Number: 17846358
• Product Code: CBK
• UDI-Device Identifier: 00855573007044
• UDI-Public: (01)00855573007044(11)201124(10)204804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: ADULT, PASSIVE, OXYGEN, BLUE
• Device Catalogue Number: PRT-00793-001
• Device Lot Number: 204804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2020
• 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 Sex: Unknown