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

Model Number	V+C, Japanese
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction

• 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: 50910491
• Report Number: 3013095415-2026-00632
• Device Sequence Number: 20169710
• Product Code: CBK
• UDI-Device Identifier: 00850018761116
• UDI-Public: (01)00850018761116(11)220209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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+C, Japanese
• Device Catalogue Number: PRT-01098-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2022
• 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