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

Model Number	ADULT, ACTIVE, HEATED, OXYGEN, BLUE
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to ventec that the device was displaying a "patient circuit disconnect" alarm.The reporter advised that they believed there was an issue with the patient circuit (adult, active, heated, oxygen, blue).After trying multiple circuits unsuccessfully, the patient was then placed on another manufacturer's device for support.There was patient involvement associated with the reported event, however, there were no reports of patient harm as a result of the reported issue.No further details about the patient or the event were provided.Ventec has reached out to the reporter in order to obtain additional information about the patient and the event, but no response has been received.
Additional Manufacturer Narrative
H6: the patient circuit was not returned to ventec for evaluation.The reporter advised that it was disposed of following the event.The cause of the reported issue could not be determined.

• Brand Name: VOCSN PATIENT BREATHING PACKAGE
• 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: 19833742
• Report Number: 3013095415-2024-00549
• Device Sequence Number: 7504957
• Product Code: CBK
• UDI-Device Identifier: 00850018761062
• UDI-Public: (01)00850018761062(11)231017(10)234202
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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: ADULT, ACTIVE, HEATED, OXYGEN, BLUE
• Device Catalogue Number: PRT-00798-004
• Device Lot Number: 234202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown