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

Model Number	V+C+PRO, JAPANESE
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized service provider (asp) contacted ventec to report that the device had unexpectedly powered off during use.No further details about the patient were available, however, there were no reports of patient harm as a result of the reported issue.The asp confirmed that the patient survived the reported event.Following the event, the asp advised that personnel observed that the device began rebooting by itself while sitting at a nurses station.
Additional Manufacturer Narrative
H6: the device was received by ventec where its electronic records (system logs) were downloaded for analysis.Ventec observed data which confirmed that the device did power off unexpectedly during the reported event.Ventec further confirmed that the device had logged multiple reboot events.Ventec replaced the control board to resolve the reported issue.Proper device operation was confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the control board.

• 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: 22191146
• Report Number: 3013095415-2025-00513
• Device Sequence Number: 12971021
• Product Code: CBK
• UDI-Device Identifier: 00855573007785
• UDI-Public: (01)00855573007785(11)210726
• 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
• Report Date (Section B): 06/11/2025

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 Model Number: V+C+PRO, JAPANESE
• Device Catalogue Number: PRT-00900-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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