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

Model Number	V+O+C+S+N+PRO, JAPANESE
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2023
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's exhaled tidal volume (vte) levels were low.There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001: section d4, model #, of the initial medwatch report stated: prt-00490-100.Section d4, model #, of the initial medwatch report should have stated: v+o+c+s+n+pro, japanese.Section d4, udi #, of the initial medwatch report stated: (b)(4).Section d4, udi #, of the initial medwatch report should have stated: (b)(4).New information for supplemental medwatch report 001 : h6: the device will not be returned to ventec for evaluation.The authorized third party service provider (asp) will evaluate and repair the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Additional Manufacturer Narrative
H6: upon further consideration, the authorized service provider (asp) elected to return the device to ventec for evaluation.The device was evaluated by ventec where the reported issue of it delivering low vte (exhaled tidal volume) could not be confirmed.During testing, however, ventec observed that the device was instead delivering higher than expected vte.Ventec replaced the internal flow transducer (ift) and external flow module (efm) to resolve the observed issue, which could have also caused the low vte that was originally reported.Proper device operation was then observed through functional and performance testing.The investigation determined that the likely cause of the reported issue was the ift and 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17608284
• Report Number: 3013095415-2023-00526
• Device Sequence Number: 7570758
• Product Code: CBK
• UDI-Device Identifier: 00855573007761
• UDI-Public: (01)00855573007761(11)210826
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2023

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+O+C+S+N+PRO, JAPANESE
• Device Catalogue Number: PRT-00490-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/08/2024; 05/07/2025
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/05/2024; 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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