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

Model Number	VOCSN, ENGLISH
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to ventec that the device's alarm was not working as expected.The reporter advised that the device did not provide a patient circuit disconnect alarm when the patient had been disconnected.There was patient involvement associated with the reported event; however, there were no reports of patient harm as a result of the reported issue.No further details about the patient was provided.Ventec has made multiple attempts to contact the reporter in order to obtain additional information, but no response has been received.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of the device not alarming for patient circuit disconnect could not be duplicated or confirmed.Upon receipt of the device, ventec downloaded its electronic records (system logs) for analysis and observed that device previously logged multiple patient circuit disconnect alarms as expected.The device was then evaluated by ventec where the issue of it not alarming for patient circuit disconnect could not be duplicated.The alarm was tested on both customer presets (active and passive) and sounded without issue.Proper device operation was confirmed through functional and performance testing.The cause of the reported issue could not be determined.

• Brand Name: VOCSN
• Common Device Name: 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: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 22868741
• Report Number: 3013095415-2025-00747
• Device Sequence Number: 7779133
• Product Code: CBK
• UDI-Device Identifier: 00855573007006
• UDI-Public: (01)00855573007006(11)180130
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: VOCSN, ENGLISH
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown