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

Model Number	PRT-00490-001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to ventec that the ventilator had alarmed due to low inspiratory pressure as well as low minute volume.The device's exhaled tidal volume (vte) levels were also low.The patient was manually ventilated (bagged) until he could be placed on another ventilator 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 were provided.
Additional Manufacturer Narrative
The reporter, a respiratory therapist (rt), advised ventec that the patient had recently transitioned from another ventilator manufacturer to the vocsn for home care.The patient was placed on the vocsn and was initially doing fine until the alarms began.The rt requested that ventec contact the nurse who had reported the alarms to him so that the issue could be investigated and troubleshot, accordingly.A ventec clinical specialist contacted the nurse to provide both technical and clinical support.The nurse was advised by the ventec clinical specialist that updating the settings to better support the patient's condition would likely resolve the reported issues; however, the nurse was uncomfortable operating the vocsn and since the patient is at home (and not in a hospital) she did not want to make any changes to the vocsn settings without having first received orders from medical personnel.The family of the patient advised they would contact the distributor who owns the device and work with them with regards to next steps.The device was not returned to ventec for evaluation.The cause of the reported issue could not be determined.This mdr has been reassessed as reportable after conducting a retrospective review of prior complaint records.As this has been reassessed, it will appear to be a late mdr.

• 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: 13115505
• Report Number: 3013095415-2021-00784
• Device Sequence Number: 13646433
• Product Code: CBK
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/07/2021

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: PRT-00490-001
• Device Catalogue Number: PRT-00490-001
• 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: 12/07/2021
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• 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: Male