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

Model Number	EVOLUTION 3E T
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The blower was returned to event medical for further analysis.Visual inspection of the blower showed sign of cracks next to the housing screws.The analysis concluded that the blower damage resulted from a faulty blower with loose or faulty impeller which came into contact with the housing of the blower leading to the malfunction and triggering the blower fault alarm.If additional information becomes available in the future, a supplemental report will be issued.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 or Problem Description
The initial reporter located outside the u.S.Reported ventilator displayed the blower fault alarm while ventilating on a patient.The patient was removed from the ventilator and placed on manual ventilation with no harm reported.Service inspected the ventilator and noticed that the device blower was damaged.The blower was replaced to address the issue.

• 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: 16679006
• Report Number: 3006135941-2023-00009
• Device Sequence Number: 17585642
• Product Code: CBK
• UDI-Device Identifier: 00860008873606
• UDI-Public: 00860008873606
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K113743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2023

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: 03/09/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2021
• 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