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

Model Number PRT-00490-001

Device Problem Connection Problem (2900)

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

Event Date 08/31/2023

Event Type  malfunction  

Event Description

It was reported that the device needed service.During the device's evaluation, ventec observed that it had previously logged multiple patient circuit disconnect alarms in its memory.There were no reports of patient involvement associated with the reported event.

Manufacturer Narrative

H6: ventec received the device for evaluation and downloaded its electronic records for analysis.Upon review of the electronic records, ventec observed that the device had logged multiple patient circuit disconnect alarms in its memory, confirming the reported issue.Ventec then tested the device using the appropriate patient circuit according to the patient settings but the reported issue could not be duplicated or confirmed.Proper device operation was confirmed through functional and performance testing.The cause of the reported issue could not be conclusively determined.

• 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: 17857604
• MDR Text Key: 324782541
• Report Number: 3013095415-2023-00599
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00855573007792
• UDI-Public: 0100855573007792
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-00490-001
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2020
• 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