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

Model Number PRT-01201-000

Device Problem Defective Alarm (1014)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Ventec will perform an evaluation of the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.

Event Description

It was reported to ventec that the device's alarms were not working.There was no patient involvement associated with the reported event.

Manufacturer Narrative

H6: the device was evaluated by ventec where the reported issue of its alarms not working was confirmed.Ventec replaced the device's front panel board to resolve the reported issue.Proper device operation was then observed through functional and performance testing.The investigation determined that the cause of the reported issue was the front panel board.

• 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: atul sinha ; 22002 26th ave se; bothell, WA 98021 ; 2067612204
• MDR Report Key: 13691293
• MDR Text Key: 287125028
• Report Number: 3013095415-2022-00195
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

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
• Device Operator: Health Professional
• Device Model Number: PRT-01201-000
• Device Catalogue Number: PRT-01201-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2020
• 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