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

Model Number	V*HOME, ENGLISH
Medical Device Problem Codes	Device Alarm System (1012); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Ventec received a copy of a voluntary medwatch report which advised of the following event: "the ventilator circuit disconnect alarm did not alarm when the patient became disconnected from the ventilator.Family also reported the ventilator sounded different than it normally did and stated the pressure sounded more 'muffled' coming from the vent (not as loud)." ventec reached out to the initial reporter for additional information about the patient.Ventec was advised that they were unable to share any additional information about the patient, but did confirm that there was no patient harm as a result of the reported issue.
Additional Manufacturer Narrative
H6: the customer has advised that they do not plan to return the device at this time.In the event that the device is returned for an evaluation, ventec will submit a follow-up report as defined by 21 cfr 803.56.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 device has not been returned to ventec for an evaluation.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: 25250679
• Report Number: 3013095415-2026-00335
• Device Sequence Number: 10548263
• Product Code: CBK
• UDI-Device Identifier: 00855573007822
• UDI-Public: (01)00855573007822(11)250624
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: Lay User/Patient
• Device Model Number: V*HOME, ENGLISH
• Device Catalogue Number: PRT-01444-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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 Age: 12 MO
• Patient Sex: Male
• Patient Weight: 10 KG