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

Model Number	V*Home, English
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/21/2026
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: 50952873
• Report Number: 3013095415-2026-00602
• Device Sequence Number: 18529811
• Product Code: CBK
• UDI-Device Identifier: 00855573007822
• UDI-Public: (01)00855573007822(11)250204
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: V*Home, English
• Device Catalogue Number: PRT-01444-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown