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

Model 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	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: the authorized third party service provider (asp) has elected to return the device to ventec for evaluation.Ventec will perform evaluate and repair 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 third party service provider (asp) contacted ventec to report that the device's exhaled tidal volume (vte) levels were low.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001: section b3, date of event, of the initial medwatch report stated: 1/13/2025.Section b3, date of event, of the initial medwatch report should have stated: 1/9/2025.New information for supplemental medwatch report 001: h6: ventec has received the device and will perform an evaluation.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.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of its exhaled tidal volume (vte) levels being low was confirmed.Ventec replaced the external flow module (efm) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the efm.

• 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: 21194154
• Report Number: 3013095415-2025-00072
• Device Sequence Number: 3326453
• Product Code: CBK
• UDI-Device Identifier: 00855573007785
• UDI-Public: (01)00855573007785(11)220104
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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: Other
• Device Model Number: V+C+PRO, JAPANESE
• Device Catalogue Number: PRT-00900-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/27/2025; 03/20/2025
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 02/22/2025; 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• 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