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	04/24/2026
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 low.Additionally, it was reported that the device's breath rate was out of specification.However, the asp could not advise whether it was delivering below or above spec, so it is being reported out of an abundance of caution.There were no reports of patient use associated with the reported issue.
Additional Manufacturer Narrative
H6: the device was not available for return to ventec for evaluation.The device was evaluated by the authorized service provider (asp) where the reported issues of its exhaled tidal volume (vte) levels being low and it providing an unexpected breath rate were initially confirmed, however, upon subsequent testing of the device, the issues could no longer be duplicated.Proper device operation was confirmed through functional and performance testing.The cause of the reported issues could not be determined.

• 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: 25325981
• Report Number: 3013095415-2026-00352
• Device Sequence Number: 18549095
• Product Code: CBK
• UDI-Device Identifier: 00850018761154
• UDI-Public: (01)00850018761154(11)200427
• 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): 05/28/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2020
• 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