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

Model Number	V+PRO, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device needed service.As part of the device investigation upon receiving the device, ventec reviewed a copy of the authorized service provider's (asp's) service report which stated that the device had measured higher peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the device was evaluated by the authorized service provider (asp) where the reported issues of it delivering higher than set peep (positive end expiratory pressure) and low vte (exhaled tidal volume) were confirmed.The asp replaced the external flow module (efm) and the internal flow transducer (ift) to resolve the reported issues.The asp then returned the device to ventec due to an unrelated issue.Ventec was able to confirm that the repairs completed by the asp resolved the reported issue.Proper device operation was confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the efm and 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: 25344212
• Report Number: 3013095415-2026-00366
• Device Sequence Number: 10465048
• Product Code: CBK
• UDI-Device Identifier: 00850018761154
• UDI-Public: (01)00850018761154(11)200601
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2026

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 Model Number: V+PRO, ENGLISH
• Device Catalogue Number: PRT-01185-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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