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

Model Number	V+C, ENGLISH
Medical Device Problem Codes	Device Alarm System (1012); Output Problem (3005)
Health Effect - Clinical Codes	Arrhythmia (1721); Cyanosis (1798); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The fda provided ventec with a copy of medwatch report mw5186083 which stated the following: "my husband has been on a ventilator 24/7 for approximately 8 years.Last week his dme (durable medical equipment) switched him from his old vent to a vocsn (ventilation, oxygen concentrator, cough assistance, suction, and nebulizer).My "training" lasted approximately 15 minutes.I have since learned that you should never switch a ventilator at home.It should be done in the hospital under the supervision of a physician.The very next day, it was by sheer chance that i checked on him when i did.I found him blue, unresponsive, in a-fib with o2 of 35%.The alarm on the vent never sounded.Whilst calling 911, i switched him back to his old vent and it immediately began alarming.He nearly lost his life due to this malfunction.He remains in the icu, returning home tomorrow under the care of a different dme company.I have also learned that the circuits viemed has been providing are not meant for invasive ventilation.They are, in fact, bipap/cpap hoses which do not provide the correct pressures.I am very concerned this will happen to someone else who may not be as "lucky" as my husband.The company is requiring the return of the machine.Once back in their possession, they will be able to wipe its memory and any evidence or information as to what exactly malfunctioned and/or was set up incorrectly.Thank you for your time and consideration in this matter." there was patient involvement associated with the reported event.The patient was hospitalized as a result of the reported event.Per mw5186083 the initial reporter requested to remain anonymous, therefore ventec has provided the dme's contact information in section e.
Additional Manufacturer Narrative
H6: ventec has made multiple unsuccessful attempts to contact the dme, asking whether the device will be returned to ventec for evaluation.The dme has not responded to these requests.In the event that the device is received for an evaluation, ventec will submit a follow-up report as defined by 21 cfr 803.56.Ventec performed a review of the device's manufacturing records which showed all requirements were met.Final test specifications were acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.Trend analysis and risk analysis were considered acceptable.The vocsn clinical and technical manual states the following [p.24]: "vocsn was designed for use with active, passive, valveless, or mouthpiece ventec one-circuits.Do not use third-party patient circuits with vocsn.Assemble ventec one-circuits and ventec one-circuit accessories using the procedures and sequences depicted in this manual." the device was not returned to ventec for evaluation.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: 25038380
• Report Number: 3013095415-2026-00273
• Device Sequence Number: 9643295
• Product Code: CBK
• UDI-Device Identifier: 00855573007730
• UDI-Public: (01)00855573007730(11)231207
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

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: Lay User/Patient
• Device Model Number: V+C, ENGLISH
• Device Catalogue Number: PRT-01098-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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: Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male