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 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

H6: the device was evaluated by ventec where the reported issues of lower peep (positive end expiratory pressure) than set and low exhaled tidal volume (vte) levels was confirmed.Ventec replaced the internal flow transducer (ift) and external flow module (efm) to resolve the reported issues.Proper device operation was observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift and efm.

Event Description

It was reported that the device needed service.During the device evaluation ventec observed that the ventilator measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.There were no reports of patient involvement associated with the reported event.

Manufacturer Narrative

Section b5, describe event or problem, of the initial medwatch report stated: it was reported that the device needed service.During the device evaluation ventec observed that the ventilator measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.There were no reports of patient involvement associated with the reported event.Please see section b5, describe event or problem, for what the initial medwatch report should have stated.Section h10, additional manufacturer narrative, of the initial medwatch report stated: h6: the device was evaluated by ventec where the reported issues of lower peep (positive end expiratory pressure) than set and low exhaled tidal volume (vte) levels was confirmed.Ventec replaced the internal flow transducer (ift) and external flow module (efm) to resolve the reported issues.Proper device operation was observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift and efm.Section h10, additional manufacturer narrative, of the initial medwatch report should have stated: h6: the device was evaluated by ventec where the reported issues of it measuring lower peep (positive end expiratory pressure) than set and low exhaled tidal volume (vte) levels was confirmed.Ventec replaced the internal flow transducer (ift) and external flow module (efm) to resolve the reported issues.Ventec confirmed that the device had previously logged patient circuit disconnect and high peep alarms, however, these issues could not be duplicated during testing.If these issues were intermittent, they would be resolved through the replacement of the ift and efm.Proper device operation was observed through functional and performance testing.The investigation determined that the cause of the reported issues was the ift and efm.

Event Description

It was reported that the device needed service.During the device evaluation ventec observed that it measured lower peep (positive end expiratory pressure) than set and that its exhaled tidal volume (vte) levels were low.In addition, the device had previously logged patient circuit disconnect and high peep alarms.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: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18078036
• MDR Text Key: 327444900
• Report Number: 3013095415-2023-00696
• 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,Distributor
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• 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