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	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized third party service provider (asp) contacted ventec to report that the device was providing an alarm indicating very low fio2 (fraction of inspired oxygen) readings.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the authorized third party service provider will further 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: the authorized third party service provider (asp) elected to return the device to ventec for evaluation and repair.The device was evaluated by ventec where the reported issue of it alarming due to very low fio2 (fraction of inspired oxygen) readings was confirmed through a review of its electronic records (system logs).Ventec was unable to duplicate the very low fio2 alarm during testing.During the evaluation, however, ventec also observed that the device was providing inaccurate fio2 readings.Ventec replaced the oa2 board and metering valve to resolve both reported issues.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the oa2 board and metering valve, which did have a broken drive band.

• 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: 20185949
• Report Number: 3013095415-2024-00641
• Device Sequence Number: 8363939
• Product Code: CBK
• UDI-Device Identifier: 00855573007211
• UDI-Public: (01)00855573007211(11)171208
• 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
• Report Date (Section B): 08/18/2024

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: 08/18/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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