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

Model Number	V*Home, English
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device needed service.Upon receipt of the device, ventec downloaded its electronic records (system logs) for analysis and observed that the device had previously powered off by itself.There was patient involvement associated with the reported event; however, there was no patient harm as a result of the reported issue.
Additional Manufacturer Narrative
H6: ventec evaluated the device's electronic records (system logs) where the reported issue of it powering off unexpectedly by itself was confirmed.Ventec replaced the control board to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The cause of the reported issue was the control board.

• 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: 50885555
• Report Number: 3013095415-2026-00617
• Device Sequence Number: 9791964
• Product Code: CBK
• UDI-Device Identifier: 00855573007822
• UDI-Public: (01)00855573007822(11)240729
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: Lay User/Patient
• Device Model Number: V*Home, English
• Device Catalogue Number: PRT-01444-000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Race: White