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

Model Number	VOCSN-VC PRO, ENGLISH
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported to ventec by a third party service provider that the lcd touchscreen on the device was unresponsive.There were no reports of patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the device was not returned to ventec for evaluation.The device was evaluated by an authorized service provider (asp) where the reported issue of an unresponsive lcd touchscreen was confirmed.The asp replaced the device's front case assembly to resolve the reported issue.The front case assembly includes a replacement lcd touchscreen, front panel board pca and lcd cable, all of which have the potential to contribute to the reported unresponsive touchscreen issue.Proper device operation was observed through functional and performance testing.The investigation determined that the cause of the reported issue was the front case assembly, however, further component level cause could not be conclusively determined.
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: vocsn-vc 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).

• 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: 16174906
• Report Number: 3013095415-2023-00023
• Device Sequence Number: 2429389
• Product Code: CBK
• UDI-Device Identifier: 00855573007433
• UDI-Public: (01)00855573007433(11)180516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2022

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: VOCSN-VC PRO, ENGLISH
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 05/11/2023; 08/21/2025
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 05/15/2023; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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