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

Model Number PRT-01184-000

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

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

H6: the device was not returned to ventec for evaluation.The device was evaluated by an authorized service provider (asp) where the reported issues of it displaying a patient circuit disconnect alarm and measuring lower peep (positive end expiratory pressure) than set was confirmed.The asp replaced the internal flow transducer (ift) to resolve the reported issues.Proper device operation was observed through functional and performance testing.The investigation determined that the root cause of the reported issues was the ift.Serviced by asp.

Event Description

An authorized third party service provider (asp) contacted ventec to report that the ventilator measured lower peep (positive end expiratory pressure) than set and displayed a patient circuit disconnect alarm.There were no reports of patient involvement associated with the reported event.

• 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17130577
• MDR Text Key: 317208731
• Report Number: 3013095415-2023-00372
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00855573007860
• UDI-Public: 0100855573007860
• 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: Other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-01184-000
• Device Catalogue Number: PRT-01184-000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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