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); Output Problem (3005)
Health Effect - Clinical Code	Distress (2329)
Date of Event	11/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The following event was reported to ventec via email by a facility biomedical technician: "respiratory therapy sent me a v+ pro that is reporting too high of pressures.From the little verifications i can do it appears to be working fine on the biomet side of things.But there is clearly a problem.We have had the vent for about 5 months now." the biomedical technician responded to ventec¿s request for additional details by providing the following: "high peak pressures.This vent has greater than 50 pressures.Set up another vent with same settings, peak pressure was significantly lower." ventec then received additional information about the patient and the event from the facility respiratory therapy (rt) clinical coordinator: "no alarms, visual signs of distress (vent desynchrony, spike in vitals) we tried two different vocsns on a test lung with the same settings.This one had significantly higher peak pressures than the other one." ventec then asked what peep was set to vs what reading was observed during the patient event.The rt clinical coordinator advised, "it was set at 10 and reading 10, according to the charting." the rt clinical coordinator advised ventec that the patient exhibited visual signs of distress during the event.The patient was placed on a different ventilator for support and their distress was immediately resolved.The patient survived the reported event.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of high peak pressures could not be duplicated or confirmed.Ventec downloaded the device¿s electronic records (system logs) for analysis, but no discrepancies were observed.Ventec also evaluated the device¿s alarm system and confirmed proper operation, noting that alarms were present when (for example) the patient circuit had become disconnected.Proper device operation was confirmed through functional and performance testing.Ventec's investigation did not reveal any device performance issues which may have contributed to the patient's alleged distress.The cause of the reported issue 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: 21154486
• Report Number: 3013095415-2025-00032
• Device Sequence Number: 13035981
• Product Code: CBK
• UDI-Device Identifier: 00855573007778
• UDI-Public: (01)00855573007778(11)230412
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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+PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White