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

Model Number	V+PRO, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Discomfort (2330); Sleep Dysfunction (2517)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the device was received by ventec, and its electronic records (system logs) were downloaded for analysis.Ventec confirmed that the device had previously logged multiple patient circuit disconnect alarms, but no further discrepancies were observed.The device was then evaluated by ventec where the reported issues of it displaying a patient circuit disconnect alarm and providing an unexpected breath rate could not be duplicated.Ventec observed that the device¿s (overall) alarm system functioned as intended and they did not observe any ventilation-related issues during the evaluation which may have contributed to the patient¿s alleged discomfort while on the device.Proper device operation was confirmed through functional and performance testing.The cause of the reported issues and the patient¿s alleged discomfort could not be determined.
Event or Problem Description
A distributor contacted ventec to report that one of their patient¿s was experiencing discomfort while on the vocsn.The distributor advised ventec of the following: "patient is complaining that when he falls asleep the vhome isn¿t compensating for his breathing.It feels like too much air is being pushed through his trach.It feels fine and comfortable when he¿s awake as he can somewhat control his breathing but once he¿s asleep it gets to be too much and ends up waking him up in a panic.Since he hasn¿t been able to get help from our rts he¿s been reading through the manual and been trying to learn everything he can regarding this therapy.He mentioned he wants his breath rate to be in a square pattern where it currently is on a ramp up pattern." the same day that ventec was contacted by the distributor, the fda provided ventec with a voluntary medwatch report (mw5166125) that had been submitted by the patient.The voluntary medwatch states the following: ¿i am a diagnosed (c1, c2) quadriplegic on a respirator which i have been for the past 30 years.On (b)(6) 2025, i switched over to a new respirator by reacthealth called vocsn and it does not work by prohibiting the patient from being able to sleep on the device.I have contacted reacthealth about the vocsn respirator and they are refusing to take the situation seriously.There are two main problems with the vocsn respirator: 1) the device was put on the market without adequate testing or 2) reacthealth has not trained anyone properly on how to use the respirator as everyone who attempts to help is guessing on how to program the device.Being on a respirator 24/7/365 is no laughing matter as the consequences are life and death on whether a device functions properly.And right now it, seems the vocsn is not able to meet the needs of people who need it the most.The vocsn respirator is intended to be a support for individuals who have various breathing issues; ranging from sleep apnea to individuals who cannot breathe due to a spinal cord injury.I personally fall in the ladder category as i physically cannot breathe on my own and have required the support of a machine since i was seven years old.What occurs is that as the patient on the vocsn starts to fall asleep, their muscles relax, causing the brain's mental state to shift from focusing exclusively on trying to control the breath the vocsn delivers to ignoring it.This results in the alarms going off, indicating that the tubes are disconnected when, in actuality, they are not.The vocsn respirator's purpose is to help people with impaired diaphragms breathe while they are either awake or asleep, which it does not accomplish.The most troublesome aspect of reacthealth vocsn respirator is its corporate structure in that they refuse to take responsibility for how the respirator works nor train people how to use it properly and pass the task onto dme providers to figure it out.Reacthealth should be willing and required to work with their customers using their product to make sure it functions correctly.The fact that reacthealth has been able to make a defective product and pass it on to the customer without any responsibility is insane, especially when it deals with a medical device.That would be like me starting a car company, knowingly making the car not safe and selling it to people by saying, "best of luck to you, and i hope you don't die." as they are walking out the door.That being said, something needs to be done with reachhealth's vocsn respirator because if something does not change soon someone is going to get hurt if not die from a faulty respirator which will open them up to litigation for designing a product, selling a product to customers, and refusing to help their customers.¿ there were no reports of patient harm as a result of the reported issue, however, the patient experienced discomfort, panic and sleep dysfunction while on the vocsn which required intervention to resolve.

• 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: 21725136
• Report Number: 3013095415-2025-00250
• Device Sequence Number: 3656800
• Product Code: CBK
• UDI-Device Identifier: 00855573007877
• UDI-Public: (01)00855573007877(11)221230
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

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: Lay User/Patient
• Device Model Number: V+PRO, ENGLISH
• Device Catalogue Number: PRT-01185-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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; Life Threatening
• Patient Age: 38 YR
• Patient Sex: Unknown
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White