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

Model Number PRT-01185-002

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

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

Event Date 09/27/2023

Event Type  malfunction  

Event Description

An authorized third party service provider (asp) contacted ventec to report that the device was unable to maintain peep (positive end expiratory pressure) and that its exhaled tidal volume (vte) levels were low.In addition, the asp reported that the device had displayed alarms indicating high peep and patient circuit disconnect.There were no reports of patient involvement associated with the reported event.

Manufacturer Narrative

H6: the device was not returned to ventec for evaluation.The device was further evaluated by the authorized service provider (asp) where the reported issues of it being unable to maintain peep (positive end expiratory pressure), having low exhaled tidal volume (vte) levels and displaying alarms for high peep and patient circuit disconnect were all confirmed.The asp replaced the external flow module (efm) 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 efm.

• 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: 18555457
• MDR Text Key: 333456258
• Report Number: 3013095415-2024-00048
• 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: Other
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PRT-01185-002
• Device Catalogue Number: PRT-01185-002
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• 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