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

Model Number	V*HOME, ENGLISH
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to ventec that the device's alarm was not working as expected.The device allegedly did not provide a patient circuit disconnect alarm when the circuit had been disconnected.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec, where the reported issue of the patient circuit disconnect alarm not alarming when the circuit was disconnected was not duplicated or confirmed.Testing verified the entire alarm system operates within specifications, providing both visual and audible alarms as expected.Proper device operation was confirmed through functional and performance testing.Ventec performed a review of the device's manufacturing records which showed all requirements were met.Final test specifications were acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.Trend analysis and risk analysis were considered acceptable.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: atul sinha ; 22002 26th ave se; bothell, WA 98021 ; 8632266285
• MDR Report Key: 25420664
• Report Number: 3013095415-2026-00398
• Device Sequence Number: 10039446
• Product Code: CBK
• UDI-Device Identifier: 00855573007822
• UDI-Public: (01)00855573007822(11)241007
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2026

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: Health Professional
• Device Model Number: V*HOME, ENGLISH
• Device Catalogue Number: PRT-01444-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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