MAUDE Adverse Event Report: NEW PORT MEDICAL INSTRUMENT, INC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360E-CN-NA
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information could not be provided due to the china personal information protection law.Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.It was reported that the e360 ventilator generated an alarm accompanied by "scorched smoke and odor" while used on a patient.It was informed that the customer isolated the issue to the cooling fan not functioning.The customer re-seated the cooling fan connections to resolve the issue.The unit was returned for use in working condition.This event was reported from the adverse reaction event centre of shanghai, rather than reported directly to medtronic by the customer.No product was returned to medtronic.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available.Further action was not required and there is insufficient information about the failure and contributing cause.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient, the e360 ventilator generated an alarm accompanied by "scorched smoke and odor".The patient outcome and intervention are unknown at this time.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEW PORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave.; costa mesa CA 92626
• Manufacturer (Section G): NEW PORT 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: 15651582
• Report Number: 2023050-2022-00030
• Device Sequence Number: 16739520
• Product Code: CBK
• UDI-Device Identifier: 10884521540910
• UDI-Public: 10884521540910
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022

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: E360E-CN-NA
• Device Catalogue Number: E360E-CN-NA
• 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: 09/27/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2014
• 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
• Patient Sex: Unknown