MAUDE Adverse Event Report: Ventec Life Systems, Inc VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	V+Pro Emergency, English
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized service provider (asp) contacted ventec to report that the device was delivering higher than set peep (positive end expiratory pressure).There were no reports of patient involvement associated with the reported issue.
Additional Manufacturer Narrative
H6: the device was initially returned to ventec for an evaluation; however, the authorized service provider (asp) who reported the issue later requested that the device be returned to them unrepaired and stated that it will not be repaired at this time.As a result, ventec could not investigate the reported issue.In the event that the device is evaluated, or additional information is received, ventec will submit a follow-up report as defined by 21 cfr 803.56.Ventec performed a review of the device's manufacturing records which showed all requirements were met.Final test specifications were acceptable.No non-conformities or anomalies were found related to this complaint when reviewing the device history record.Trend analysis and risk analysis were considered acceptable.The cause of the reported issue could not be 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; 2603 s goyer rd; kokomo IN 46902
• Manufacturer Contact: atul sinha ; 22002 26th ave se; bothell, WA 98021 ; +1(863)226-6285
• MDR Report Key: 50917801
• Report Number: 3013095415-2026-00633
• Device Sequence Number: 5344937
• Product Code: CBK
• UDI-Device Identifier: 00855573007945
• UDI-Public: (01)00855573007945(11)200612(17)220612
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2026

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 Expiration Date: 06/12/2022
• Device Model Number: V+Pro Emergency, English
• Device Catalogue Number: PRT-01201-000
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2020
• 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