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

Model Number	VOCSN-VC PRO, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by ventec where the reported issue of the device providing low fio2 (fraction of inspired oxygen) readings could not be confirmed.Ventec observed that the device's fio2 setting was set to 25% and that they had also set the 'low fio2 alarm to 25%.' this allowed for 0% variation/drift or requiring 100% accuracy which is not the designed accuracy expectation.The vocsn is designed to be accurate to within 10% of its fio2 setting.At the 25% fio2 setting, the device was observed to be running at 24.5% fio2, well within tolerance (between 22.5 - 27.5%).Vocsn clinical and technical manual states in the control accuracy section [p.197], fio2 accuracy is, "±10% of setting, or ±3% oxygen, whichever is greater." proper device operation was observed through functional and performance testing.The investigation determined that the root cause of the reported issue was user error.
Event or Problem Description
It was reported to ventec that the device was alarming due to low fio2 (fraction of inspired oxygen) readings.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001: section d1, brand name, of the initial medwatch report stated: vocsn.Section d1, brand name, of the initial medwatch report should have stated: vocsn-vc.Section d4, model #, of the initial medwatch report stated: prt-00900-001.Section d4, model #, of the initial medwatch report should have stated: vocsn-vc pro, english.Section d4, udi #, of the initial medwatch report stated: (b)(4).Section d4, udi #, of the initial medwatch report should have stated: (b)(4).

• Brand Name: VOCSN-VC
• 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 16376413
• Report Number: 3013095415-2023-00103
• Device Sequence Number: 5708744
• Product Code: CBK
• UDI-Device Identifier: 00855573007433
• UDI-Public: (01)00855573007433(11)181213
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: VOCSN-VC PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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