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

Model Number	ADULT, ACTIVE, HEATED, BLUE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: ventec received the broken patient circuit (adult, active, heated, blue).The circuit was examined visually which confirmed the reported issue.Ventec observed that the circuit bond joint had separated at the active valve transducer housing to valve mount housing.Ventec continues to investigate the reported issue.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 (adult, active, heated, blue) had broken during use.There was patient use associated with the reported event.The patient was placed on their back up ventilator.The reporter advised that there was no 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: 22821755
• Report Number: 3013095415-2025-00730
• Device Sequence Number: 9750459
• Product Code: CBK
• UDI-Device Identifier: 00855573007921
• UDI-Public: (01)00855573007921(11)240601(10)242237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025

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: ADULT, ACTIVE, HEATED, BLUE
• Device Catalogue Number: PRT-00795-002
• Device Lot Number: 242237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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