MAUDE Adverse Event Report: Ventec Life Systems, Inc VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	V+O+C+S+N+Pro, English
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury

• 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; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: atul sinha ; 22002 26th ave se; bothell, WA 98021 ; +1(863)226-6285
• MDR Report Key: 50941194
• Report Number: 3013095415-2026-00635
• Device Sequence Number: 18822802
• Product Code: CBK
• UDI-Device Identifier: 00855573007792
• UDI-Public: (01)00855573007792(11)250926
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: V+O+C+S+N+Pro, English
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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