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

Model Number PRT-01201-000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that the device needed service.During the device's evaluation, ventec observed that it was displaying a patient circuit disconnect alarm.There were no reports of patient involvement associated with the reported event.

Manufacturer Narrative

H6: the device was evaluated by ventec where the reported issue of it displaying a patient circuit disconnect alarm was confirmed.Ventec replaced the external flow module (efm) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the efm.

• 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; 2603 s goyer rd; kokomo IN 46902
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18582630
• MDR Text Key: 333927425
• Report Number: 3013095415-2024-00075
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00855573007945
• UDI-Public: 0100855573007945
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PRT-01201-000
• Device Catalogue Number: PRT-01201-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• 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