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

Model Number	V+PRO EMERGENCY, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized service provider (asp), contacted ventec to report that the device's exhaled tidal volume (vte) levels were not within specification.Ventec reached out to the asp for clarification and was advised that the technician did not document the values observed.Ventec has elected to report this out of an abundance of caution, as the device's vte levels may have been low.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the device was not returned to ventec for an evaluation.The device was evaluated by an authorized service provider (asp) where the reported issue of it delivering vte (exhaled tidal volume) out of specification, which could have resulted in low vte, was confirmed.The asp replaced the internal flow transducer (ift) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the ift.

• Brand Name: VOCSN
• 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; 2603 s goyer rd; kokomo IN 46902
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 24678221
• Report Number: 3013095415-2026-00159
• Device Sequence Number: 21383522
• Product Code: CBK
• UDI-Device Identifier: 00855573007945
• UDI-Public: (01)00855573007945(11)200813(17)220813
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: Other
• Device Expiration Date: 08/13/2022
• Device Model Number: V+PRO EMERGENCY, ENGLISH
• Device Catalogue Number: PRT-01201-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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