MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	V+C+S+N+PRO, ENGLISH
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to a ventec ventilation product support specialist that the device alarmed and powered off by itself during use.The reporter advised ventec that after the device powered off, they removed the patient from the ventilator and began to provide manual ventilation.The ventilator was then restarted but powered off by itself again.The reporter advised that there was no harm to the patient as a result of the reported issue, however, the incident necessitated medical intervention in order to prevent permanent damage/impairment to the patient (manual ventilation).No further details about the patient or the event were provided.Ventec has made multiple attempts to contact the reporter in order to obtain additional information about the patient, however, no response has been received.
Additional Manufacturer Narrative
H6: ventec will perform an evaluation of the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Additional Manufacturer Narrative
H6: upon receipt of the device ventec downloaded its electronic records (system logs) for analysis and confirmed that it had powered off by itself during the reported event.Ventec then examined the device but was unable to duplicate the reported issue during testing.Ventec replaced the control board to resolve the issue.Proper device operation was confirmed through functional and performance testing.The investigation determined that 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; 2603 s goyer rd; kokomo IN 46902
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 22246142
• Report Number: 3013095415-2025-00522
• Device Sequence Number: 7915229
• Product Code: CBK
• UDI-Device Identifier: 00855573007860
• UDI-Public: (01)00855573007860(11)201105
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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+C+S+N+PRO, ENGLISH
• Device Catalogue Number: PRT-01184-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male