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

Model Number UNKNOWN

Device Problem Data Problem (3196)

Patient Problem Hypoxia (1918)

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

The customer did not return the device to ventec for an evaluation.The customer sent a sample of reports that were generated by a device to ventec for an evaluation.Ventec reviewed the reports and ventec was able to provide the customer with updated reports that addressed her concerns.The ventec clinician also provided training to the user on where pressures need to be at and how to setup volume targeted ventilation.This resolved the reported issue with the doctor.

Event Description

As reported on medwatch report mw5093809 " pt has als with respiratory/diaphragm paralysis.She is using the new vocsn non invasive ventilation system.Obtained overnight pulse ox indicating 90% of the night is spent in hypoxic range: very dangerous.This is no way to obtain a download of usage/tidal volume/ triggered breaths from the vocsn.My concern is: it is not working and not ventilating the pt, and there is no way for me to assess if the machine is working or not.Design defect and design flaw which could result in death of the pt.Fda safety report (b)(4)." a ventec clinician spoke with the doctor and what was reported to ventec was that the doctor was unable to obtain data from the device and unable to figure out how to adjust the ventilation settings due to not having the data.The ventec clinician clarified with the doctor that there was no patient harm associated with the reported issue.

• Brand Name: VOCSN
• Type of Device: 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: 11536680
• MDR Text Key: 243054264
• Report Number: 3013095415-2021-00010
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1