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

Model Number	V+O+C+S+N+PRO, ENGLISH
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
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 did not provide a patient circuit disconnect alarm when the patient was removed from the ventilator.There was patient involvement associated with the reported event.The patient had gone into cardiac arrest and personnel had removed the ventilator in order to care for the patient.There was no allegation that the device use had contributed to the patient's cardiac arrest, only that personnel had expected to hear the alarm when the patient was disconnected from the ventilator.The patient survived the reported event.Ventec made multiple attempts to contact the initial reporter in order to obtain patient information, but no response has been received.
Additional Manufacturer Narrative
H6: the initial reporter responded to ventec's requests for additional information about the patient.The initial reporter advised that the date of the event was actually 1/22/2026.As a result, section b3 date of event has been updated from 1/29/2026 to 1/22/2026.Additionally, sections a1, a2, a3a, a4, a5, and b7 have all been updated accordingly.Ventec continues to investigate the reported issue.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.

• 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; 22002 26th ave se WA 98021
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 24645977
• Report Number: 3013095415-2026-00139
• Device Sequence Number: 10207906
• Product Code: CBK
• UDI-Device Identifier: 00855573007792
• UDI-Public: (01)00855573007792(11)201215
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Followup
• Report Date (Section B): 03/19/2026

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+O+C+S+N+PRO, ENGLISH
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 05/15/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/23/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic