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

Model Number	EVOLUTION 3E T
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Event description: the initial reporter located outside the u.S.Reported that while in use on a patient, the evolution ventilator generated no oxygen supply alarm.The patient was removed from the ventilator and placed on an alternate ventilator with no injury reported.Manufacturer narrative: the third party service personnel (sp) inspected the ventilator and confirmed the reported issue.Sp replaced the device's oxygen pressure 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 s pecifications.The manufacturer's investigation is ongoing.Event medical will submit a supplemental if additional information becomes available.
Additional Manufacturer Narrative
The third party service personnel (sp) inspected the ventilator and confirmed the reported issue.Sp replaced the device's system daufghter 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: 15756466
• Report Number: 3006135941-2022-00005
• Device Sequence Number: 14670856
• Product Code: CBK
• UDI-Device Identifier: 00860008873606
• UDI-Public: 00860008873606
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2022
• 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 Age: 62 YR
• Patient Sex: Male