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

Catalog Number	V+C+PRO, JAPANESE
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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
An authorized service provider (asp) contacted ventec to report that the device was delivering low inspiratory pressure.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 or the event were provided.Ventec has requested additional information about the patient, but no response has been received.
Event or Problem Description
An authorized service provider (asp) contacted ventec to report that the device was delivering low inspiratory pressure.There was patient involvement associated with the reported event; however, there were no reports of patient harm as a result of the reported issue.The initial reporter responded to ventec's request for patient information and stated that no further information is available.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 ¿ section b5, describe event or problem, of the initial medwatch report stated: an authorized service provider (asp) contacted ventec to report that the device was delivering low inspiratory pressure.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 or the event were provided.Ventec has requested additional information about the patient, but no response has been received.Section b5, describe event or problem, of the initial medwatch report should have stated: an authorized service provider (asp) contacted ventec to report that the device was delivering low inspiratory pressure.There was patient involvement associated with the reported event; however, there were no reports of patient harm as a result of the reported issue.The initial reporter responded to ventec's request for patient information and stated that no further information is available.
Additional Manufacturer Narrative
H6: upon receipt of the device, ventec downloaded it's electronic records (system logs) for analysis.Ventec confirmed that the device had previously logged alarms due to low inspiratory pressure, as well as patient circuit disconnect, however, those alarms did not occur on the reported date of event.The device was then evaluated by ventec, but the reported issues of low inspiratory pressure and patient circuit disconnect alarms could not be duplicated.Proper device operation was confirmed through functional and performance testing.The cause of the reported issues 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: 23316423
• Report Number: 3013095415-2025-00900
• Device Sequence Number: 12003856
• Product Code: CBK
• UDI-Device Identifier: 00855573007211
• UDI-Public: (01)00855573007211(11)180201
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: Health Professional
• Device Catalogue Number: V+C+PRO, JAPANESE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 11/18/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/22/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2018
• 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