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

Model Number PRT-01100-100

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

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

H6: ventec will perform an evaluation of the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.

Event Description

An authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm and stopped ventilating.There was no patient involvement associated with the reported event.

Manufacturer Narrative

Corrected information for supplemental medwatch report 001: section b5, describe event or problem, of the initial medwatch report stated: an authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm and stopped ventilating.There was no patient involvement associated with the reported event.Section b5, describe event or problem, of the initial medwatch report should have stated: an authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm, alarmed due to low inspiratory pressure and then stopped ventilating.There was no patient involvement associated with the reported event.New information for supplemental medwatch report 001: h6: the device was evaluated by ventec where the reported issues of it displaying a patient circuit disconnect alarm, alarming due to low inspiratory pressure and no ventilation output was confirmed.Ventec replaced the blower to resolve the reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issues was the blower.

Event Description

An authorized third party service provider (asp) contacted ventec to report that while performing maintenance on the ventilator, the service technician observed that the it displayed a patient circuit disconnect alarm, alarmed due to low inspiratory pressure and then stopped ventilating.There was no 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; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17174232
• MDR Text Key: 317662452
• Report Number: 3013095415-2023-00394
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00850018761130
• UDI-Public: 0100850018761130
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PRT-01100-100
• Device Catalogue Number: PRT-01100-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2023
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• 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