MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC. EWPORT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360T-SY-IN
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the compressor used on this e360 ventilator was ¿burning from the inside¿.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that the compressor used on this e360 ventilator was ¿burning from the inside¿.The device was available for evaluation.The service personnel (sp) inspected the ventilator and the c235 air compressor.The sp found evidence of thermally damaged components in the compressor and replaced the compressor.The device passed all the required tests and calibrations as per the manufacturer's specifications at the time of service.The likely cause of the event was isolated in the field to a potential fault in the c235 air compressor.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the compressor used on this e360 ventilator was ¿burning from the inside¿.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Section d9 updated due to device return section h6 evaluation code conclusion updated to due device return - remove d02 and add d07 h3 device evaluation summary: updated due to device return medtronic conducted an investigation based on all information received.It was reported that the compressor used on this e360 ventilator was ¿burning from the inside¿.The device was available for evaluation.The service personnel (sp) inspected the ventilator and the c235 air compressor.The sp found evidence of thermally damaged components in the compressor and replaced the compressor.The device passed all the required tests and calibrations as per the manufacturer's specifications at the time of service.The compressor was sent to the original equipment manufacturer (oem) for further analysis.The analysis concluded that the claimed burn is the result of an electrical short circuit caused by incorrect maintenance due to the condition of the cylinder hanger.This likely led to the wiring rupture, resulting in the short circuit and subsequent pcb and insulation foam burn.Furthermore, the condition of the compressor suggests that the environment in which it was operated did not meet the standards.The substantial amount of dust in the intake filter clearly indicates improper maintenance, in violation of the manufacturer's prescribed maintenance schedule.The presence of corrosion also suggests that the humidity levels in the environment exceeded the defined limits.The cause of the event was isolated to electrical short circuit caused by incorrect maintenance of compressor.The event is included in a data monitoring plan.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: EWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16880951
• Report Number: 2023050-2023-00014
• Device Sequence Number: 15269392
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 02/25/2024
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2013
• 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: C235 AIR COMPRESSOR SN: (B)(6).
• Patient Sex: Unknown