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

Model Number	V+C+PRO, ENGLISH
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 alarm was not working as expected.The reporter advised that it would not alarm for low pressure.There were no reports of 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-00900-001.Section d4, model #, of the initial medwatch report should have stated: v+c+pro, english.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: nearly 18 months after this complaint was initially reported to ventec, the device was returned to ventec for preventative maintenance (pm), but not as it pertained to this reported issue.Ventec completed the pm procedure and confirmed proper device operation through functional and performance testing.Ventec reviewed the device¿s electronic records (system logs) and confirmed that the device had been used/run for 10,025 hours after the initial complaint was reported to ventec.Furthermore, the system logs indicated that o2 bleed in was active with the check o2 source alarm enabled.This means that when the therapy was running the oxygen did not drop <24%.Ventec also confirmed that there were no very low fio2 alarms indicating there was a fault with the o2 sensor, or <18% o2.It is possible that the initial reporter had powered the device on, turned on the low pressure o2 bleed in and did not wait the necessary 5 minutes for the sensor to warm up.As a result, the device would not have triggered the alarm until after the 5 minutes had elapsed.The reported issue of the device's alarm not functioning could not be confirmed.The cause of the reported issue could not be conclusively 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17283173
• Report Number: 3013095415-2023-00408
• Device Sequence Number: 6176847
• Product Code: CBK
• UDI-Device Identifier: 00855573007778
• UDI-Public: (01)00855573007778(11)230407
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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+C+PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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