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

Model Number	EVOLUTION 3E HP
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was requested but not provided.The third party service personnel confirmed the reported issue.Sp replaced the device's system sensor board to address the issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all event medical quality specifications.The manufacturer's investigation is ongoing.Event medical will submit a supplemental if additional information becomes available.
Event or Problem Description
Event description: the initial reporter located outside the u.S.Reported that while in use on a patient, the oxygen (o2) high pressure zero offset failed on evolution ventilator dring calibration.The patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.Manufacturer narrative: patient information was not provided.The third party service personnel confirmed the reported issue.Sp replaced the device's system sensor board to address the issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all event medical quality specifications.The manufacturer's investigation is ongoing.Event medical will submit a supplemental if additional information becomes available.

• 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 CA 92630
• Manufacturer Contact: azita hedayati ; 60 empire drive; lake forest, CA 92630 ; 9499001917
• MDR Report Key: 17033591
• Report Number: 3006135941-2023-00012
• Device Sequence Number: 12391172
• Product Code: CBK
• UDI-Device Identifier: 00860008873606
• UDI-Public: 00860008873606
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Repair
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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 HP
• 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: 05/17/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2021
• 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