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

Model Number	V+C+PRO, JAPANESE
Medical Device Problem Codes	Connection Problem (2900); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issues of it logging patient circuit disconnect alarms in its memory, as well as alarming due to low inspiratory pressure during testing were both confirmed.Ventec replaced the external flow module (efm) to resolve the reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issues was the efm.
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to request service for a device.The asp advised that the device had reportedly alarmed continuously during use.The asp further advised that they were unable to obtain the alarm history or reproduce any alarms and were requesting that ventec perform an evaluation of the device.The asp advised that there was no patient harm as a result of the reported issue.The patient was placed on a backup device for support and survived the reported event.During the device's evaluation, ventec downloaded the device's system logs for analysis.Ventec observed that on the date of the event, the device had logged patient circuit disconnect alarms in its memory.Additionally, while testing the device ventec observed that it alarmed due to low inspiratory pressure.

• 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: 19797224
• Report Number: 3013095415-2024-00531
• Device Sequence Number: 17914528
• Product Code: CBK
• UDI-Device Identifier: 00855573007785
• UDI-Public: (01)00855573007785(11)211208
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: V+C+PRO, JAPANESE
• Device Catalogue Number: PRT-00900-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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 Age: 20 YR
• Patient Sex: Male
• Patient Weight: 30 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian