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: the patient circuit was returned to ventec for evaluation.Ventec examined the returned patient circuit and the reported issue of delamination was confirmed.The circuit appeared to have the clear inner tubing delaminated from the blue spiral wrap on approximately 5 wraps near the overmolded end (ventilator side).There were no other areas of delamination observed and physical/tactile examination did not identify any other areas of delamination.The circuit was viewed under magnification which confirmed delamination due to lack of fusion between the polyolefin (clear tube) from the polypropylene (blue spiral wrap).
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 patient involvement associated with the reported event, however, there were no reports of patient harm as a result of the reported issue.No further details about the patient or the event were provided.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 -- section d1, brand name, of the initial medwatch report stated: vocsn.Section d1, brand name, of the initial medwatch report should have stated: vocsn patient breathing package.Section d4, model #, of the initial medwatch report stated: prt-00793-001.Section d4, model #, of the initial medwatch report should have stated: adult, passive, oxygen, blue.Section d4, udi #, of the initial medwatch report stated: (b)(4).Section d4, udi #, of the initial medwatch report should have stated: (b)(4).Section h5, labeled for single use, of the initial medwatch report stated: no.Section h5, labeled for single use, of the initial medwatch report should have stated: yes.

• 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: 18887817
• Report Number: 3013095415-2024-00221
• Device Sequence Number: 3038047
• 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): 02/13/2024

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: 02/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown