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

Model Number	ADULT, ACTIVE, HEATED, OXYGEN, BLUE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
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 o2 delivery tube portion of the patient circuit (adult, active, heated, oxygen, blue) had separated from the main tubing assembly.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the patient circuit (adult, active, heated, oxygen, blue) was returned to ventec, which was then forwarded on to the supplier for examination.The supplier examined the patient circuit where the reported issue of the o2 delivery tube portion of the circuit separating from the main tubing assembly was confirmed.The supplier observed that the amount of locktite4011 adhesive on the insertion surface of the o2 delivery tube was insufficient, resulting in a relatively weak bonding strength.The investigation determined that the root cause of the reported issue was supplier process due to a lack of adhesive, which created a weak bonding strength.

• 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: 19930893
• Report Number: 3013095415-2024-00573
• Device Sequence Number: 2760132
• Product Code: CBK
• UDI-Device Identifier: 00850018761062
• UDI-Public: (01)00850018761062(11)231017(10)234202
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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, ACTIVE, HEATED, OXYGEN, BLUE
• Device Catalogue Number: PRT-00798-004
• Device Lot Number: 234202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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 Sex: Unknown