MAUDE Adverse Event Report: EVENT MEDICAL LTD. EVOLUTION 3E; VENTILATOR SYSTEM

Model Number	EVOLUTION 3E T
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative: based upon all information received and based on event medical investigation the reported issue can be triggered when the exhalation valve is opening and closing very quickly to control and keep the pressure at a constant level and when the pressure reaches the high pressure alarm limit and also when there is no synchronization due to improper user settings on the device.Additionally, if the exhalation valve cover is not locked during operation of the device the valve shaft can bend, tremble will increase and the control of the pressure is more difficult.In this case there was no need to change the exhalation valve or any component.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s specifications.If additional information is provided in the future, a supplemental report will be issued.Event medicals risk analysis for this failure mode concludes that the risk is acceptable.
Event or Problem Description
The initial reporter located outside the u.S.Reported that the evolution ventilator displayed a tremble waveform during exhalation while in use on a patient.The patient was removed from the ventilator and placed on an alternate ventilator with no harm.The customer reported that the ventilator passed all tests and calibrations per manufacturer specifications prior to use on the patient.Customer used a test long to reproduce the waveform tremble issue on the unit and reported that rapid breathing and pressing the test lung when peak alarm is active may cause the tremble issue.Customer also reported that if the user does not lock the exhalation valve assembly properly, the exhalation valve can move when the patient or the test lung is being ventilated.There was no need to change the exhalation valve and service was able to calibrate the unit.
Additional Manufacturer Narrative
Manufacturer narrative: based upon all information received and based on event medical investigation the reported issue can be triggered when the exhalation valve is opening and closing very quickly to control and keep the pressure at a constant level and when the pressure reaches the high-pressure alarm limit and also when there is no synchronization due to improper user settings on the device.Additionally, if the exhalation valve cover is not locked during operation of the device the valve shaft can bend, tremble will increase and the control of the pressure is more difficult.In this case there was no need to change the exhalation valve or any component.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all event medical quality specifications.If additional information is provided in the future, a supplemental report will be issued.Event medical's risk analysis for this failure mode concludes that the risk is acceptable.

• Brand Name: EVOLUTION 3E
• Common Device Name: VENTILATOR SYSTEM
• Manufacturer (Section D): EVENT MEDICAL LTD.; 60 empire drive; lake forest CA 92630
• Manufacturer (Section G): EVENT MEDICAL LTD.; 60 empire drive; lake forest 92630
• Manufacturer Contact: azita hedayati ; 60 empire drive; lake forest, CA 92630 ; 9499001917
• MDR Report Key: 16670158
• Report Number: 3006135941-2023-00007
• Device Sequence Number: 14945547
• Product Code: CBK
• UDI-Device Identifier: 00860008873606
• UDI-Public: 00860008873606
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K113743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: EVOLUTION 3E T
• Device Catalogue Number: EVL100500-T, EVL100500-T-NF
• 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: 03/05/2023
• Supplement Date Received by Manufacturer: 03/05/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown