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

Model Number PRT-00490-001

Device Problem Defective Alarm (1014)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that the device needed service.Upon evaluation of the device, ventec observed that it did not provide an o2 concentration alarm as expected during testing.There was no patient involvement associated with the reported event.

Manufacturer Narrative

The device was evaluated by ventec where the reported issue of the device not providing an o2 concentration alarm as expected during testing was confirmed.Ventec updated the device's software to version and confirmed that the o2 concentration alarm triggered as expected during the final test.Proper device operation was observed through functional and performance testing.The cause of the device failing to alarm for o2 concentration during the initial device evaluation could not be 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: atul sinha ; 22002 26th ave se; bothell, WA 98021 ; 2067612204
• MDR Report Key: 15108970
• MDR Text Key: 302762621
• Report Number: 3013095415-2022-00657
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2022

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-00490-001
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Initial Date Manufacturer Received: 07/07/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2018
• 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