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

Model Number	VOCSN-VC PRO, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 "o2 sensor not working." no further details were provided.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: 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).New information for supplemental medwatch report 001: h6: the device was evaluated by ventec where the reported issue of its o2 sensor "not working" could not be duplicated or confirmed.Ventec did observe that there was an instance of the device logging an alarm for very low fio2 (fraction of inspired oxygen) in the system logs, but that too could not be duplicated during testing.Proper device operation was confirmed through functional and performance testing.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; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 19481545
• Report Number: 3013095415-2024-00441
• Device Sequence Number: 15434737
• Product Code: CBK
• UDI-Device Identifier: 00855573007433
• UDI-Public: (01)00855573007433(11)180801(21)113466
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/15/2024

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: Health Professional
• Device Model Number: VOCSN-VC 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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