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

Model Number	EVOLUTION 3E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
Type of Reportable Event	Death
Event or Problem Description
On february 10, 2026, event medical received an email notification from its distributor zeus medica, located in algeria, reporting two patient deaths allegedly occurring while patients were receiving therapy with event medical evolution 3e ventilators, model: evl100000-hp-nf, serial numbers:(b)(6) and later on feb 19th , distributor changed the serial numbers to (b)(6).The notification was received solely via email from the distributor.No formal complaint report, service report, or other official documentation was provided with the notification.To date, event medical has not received any direct communication from the hospital where the events allegedly occurred.Upon receipt of the distributor's email, event medical initiated its complaint handling and investigation process and requested detailed information from the distributor to allow evaluation of the reported events.Formal requests for supporting documentation and device data were sent to the distributor on february 10th, february 11th , february 12th , february 17th, meeting with dealer technician on february 24th 2026.The requested information included, but was not limited to: completed service forms, additional information forms, complete ventilator system logs, alarm and event logs, calibration records, ventilator configuration details, objective measurement data supporting the alleged volume deviation, any official documentation from the hospital.Despite multiple follow-up attempts, the distributor has not provided the requested documentation or data required to support a technical investigation of the devices.On february 20, 2026, event medical issued a formal notice of non-conformance to zeus medica due to the distributor's failure to provide the information required under: the quality agreement and distribution contract obligations so, 13485:2016 - clause 8.2.2 (complaint handling) eu mdr 2017/745 - articles 83-87 (post-market surveillance and vigilance).Fda 21 cfr 820.198 (complaint files).In an additional effort to obtain information directly from the clinical site, event medical tried to contact the hospital on march 2, 2026.No response has been received to date.Further follow-up attempts were made with the distributor on march 2 and march 6, 2026; however, the distributor has not provided the requested device information, event details, or system logs required to support the investigation.Due to the absence of objective device data, supporting documentation, and formal service records, event medical has not been able to complete a technical evaluation or determine whether the device contributed to the reported patient outcomes.At this time, the investigation remains inconclusive due to insufficient information.For this reason we cannot achieve any conclusion for this situation and we will close this mater as "insufficient evidences provided".

• Brand Name: EVENT MEDICAL
• Common Device Name: EVOLUTION 3E
• Manufacturer (Section D): EVENT MEDICAL LTD; 60 empire drive; lake forest CA 92630 0000
• Manufacturer (Section G): EVENT MEDICAL; 60 empire drive; lake forest CA 92630 0000
• Manufacturer Contact: eliana kurashima ; 60 empire drive; lake forest, CA 92630-0000 ; 9499001917
• MDR Report Key: 24563838
• Report Number: 3006135941-2026-00001
• Device Sequence Number: 15808028
• Product Code: CBK
• UDI-Device Identifier: 00860008873606
• UDI-Public: 860008873606
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K113743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EVOLUTION 3E
• Device Catalogue Number: EVOLUTION 3E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 13 MO
• Patient Sex: Unknown