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

Model Number	V+C+PRO, ENGLISH
Medical Device Problem Codes	Device Alarm System (1012); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device unexpectedly powered off during use, while it was providing ventilation, and that it did not alarm as expected.There was patient involvement associated with the reported event; however, there were no reports of patient harm as a result of the reported issue.Ventec has made multiple attempts to obtain additional information about the patient and the event, but no response was 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
Corrected information for supplemental medwatch report 001: section h6, health effect - impact code, of the initial medwatch report stated: f27 - no patient involvement.Section h6, health effect - impact code, of the initial medwatch report should have stated: f26 - no health consequences or impact.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of it unexpectedly powering off during use and not alarming as expected could not be duplicated or confirmed.Ventec downloaded the device's electronic records (system logs) for analysis but no abnormal power related events were observed.According to the system log data, the device was not used on the reported date of event (10/28/2025).There were multiple alarms logged by the device prior to and after the reported date of event.Ventec successfully triggered alarms during testing, observing that the device produced both audible and visual alarms as expected.Proper device operation was confirmed through functional and performance testing.The cause of the reported issues could not be determined.

• 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: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 23597654
• Report Number: 3013095415-2025-01003
• Device Sequence Number: 13340841
• Product Code: CBK
• UDI-Device Identifier: 00855573007778
• UDI-Public: (01)00855573007778(11)230426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2025

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: Health Professional
• Device Model Number: V+C+PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 12/19/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 11/20/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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