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

Model Number	VOCSN, ENGLISH
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device needed service.Upon evaluation of the device, ventec observed that the ventilator was unable to maintain peep (positive end expiratory pressure).There was no patient involvement associated with the reported event.
Additional Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of the ventilator being unable to maintain peep (positive end expiratory pressure) was confirmed.Ventec replaced the exhalation control module (ecm) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the ecm.

• 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: 20547194
• Report Number: 3013095415-2024-00790
• Device Sequence Number: 7481831
• Product Code: CBK
• UDI-Device Identifier: 00855573007006
• UDI-Public: (01)00855573007006(11)180910
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: Other
• Device Model Number: VOCSN, ENGLISH
• Device Catalogue Number: PRT-00490-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• 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