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

Model Number	V*HOME, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	04/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: the device has not been returned to ventec for an evaluation.The reporting facility is also an authorized service provider (asp).The initial reporter advised ventec that their service team will examine 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
Ventec received a copy of a voluntary medwatch report which stated the following: "patient's ventilator internal filter dirty, causing air to be blocked.The patient had increased work of breathing, increased respiratory rate.The ventilator was switched out and patient's symptoms resolved." the initial reporter later confirmed that the patient survived the reported event.No further details about the patient or the event were provided.Ventec requested additional information regarding the patient, however, the initial reporter declined to provide anything further.

• 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: 25340708
• Report Number: 3013095415-2026-00363
• Device Sequence Number: 10085224
• Product Code: CBK
• UDI-Device Identifier: 00855573007822
• UDI-Public: (01)00855573007822(11)241118
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 18 KG