MAUDE Adverse Event Report: COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360T-SY-IN
Medical Device Problem Codes	Smoking (1585); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ekom c235 compressor of this e360 ventilator emitted smoke.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
D10: concomitant product: ekom c235 compressor ekom compressor c235-230v-50-1; sn: (b)(6).Medtronic is the supplier (b)(4) is the manufacturer and address as follows: (b)(4), regulatory affairs specialist md conformity 421-33 7967 474 email: (b)(4) device classification name: compressor, air, portable 510k number: k091871, procode: bti, h3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the ekom c235 compressor of this e360 ventilator emitted smoke.The device was made available for evaluation.The service personnel (sp) inspected the ventilator and could not confirm the reported issue but found the compressor motor was non-operational and replaced the compressor motor.The ventilator and compressor was allowed to ventilator on a test lung for 30 minutes without any problem.The investigation could not confirm the reported issue of smoke emission.The cause of the secondary issue was isolated in the field to a potential fault in the compressor motor.The event is included in the trending and monitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received as follows: it was reported that the ekom c235 compressor of this e360 ventilator had an issue.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Section b5 updated as the customer did not actually see smoke only reported that there was a compressor issue.Section h6 device codes and evaluation codes were updated base on additional information received: device code (annex a) remove a1009 and add a1411 conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g07001 and add g04090 h3 device evaluation summary was updated due to additional information received.Edtronic conducted an investigation based upon all information received.It was reported that the ekom c235 compressor of this e360 ventilator had an issue.The device was made available for evaluation.The service personnel (sp) inspected the ventilator and found the compressor motor was non-operational, so sp replaced the compressor motor.The unit was allowed to ventilate on test lung for 30 mins without any problem.The cause of the event was isolated in the field to a potential fault in the compressor motor.The event is included in the trending and monitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21152905
• Report Number: 2023050-2025-00002
• Device Sequence Number: 15762060
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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: E360T-SY-IN
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2014
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EKOM COMPRESSOR C235-230V-50-1, SN (B)(6).
• Patient Sex: Unknown