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

Model Number PRT-01201-000

Device Problems Connection Problem (2900); Output Problem (3005)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that the device needed service.During the device evaluation, ventec observed that the ventilator was unable to maintain peep (positive end expiratory pressure) and that its exhaled tidal volume (vte) levels were low.Additionally, the device was displaying a patient circuit disconnect alarm.There was no patient involvement associated with the reported event.

Manufacturer Narrative

H6: the ventilator was evaluated by ventec where the reported issues of it being unable to maintain peep (positive end expiratory pressure), having low exhaled tidal volume (vte) levels and displaying a patient circuit disconnect alarm were confirmed.Ventec replaced the internal flow transducer (ift) to resolve the reported issues.Proper device operation was then observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift.

• 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: 18177488
• MDR Text Key: 328626488
• Report Number: 3013095415-2023-00767
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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: 10/23/2023
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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