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

Model Number E360E-JP-NA

Device Problems Defective Alarm (1014); No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/08/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter information and patient information cannot be provided due to the restriction by the japan privacy regulation.Medtronic representative reported the complaint on behalf of the customer.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 while in use, this e360 ventilator had stopped ventilation and the alarm did not sound.Repair was performed by a third party service provider tokibo (tkb).The liquid crystal display (lcd) did not display anything, 8-segment setting display was on, the alarm sound and alarm lamp did not appear; seemed that no ventilation operation was performed.When the power was turned on again, ventilation was performed but the above condition was the same.No product was returned for evaluation or made available to medtronic.The investigation could not determine a cause of the event as the medtronic employee didn't evaluate the unit.Further action was not required because the event had foreseen risk.The service history review of the ventilator is not available.The serial number indicates that the vent is >2 years old.There is not enough information available to determine if any relationship to a manufacturing fault.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 Description

It was reported that while in use on a patient this e360 ventilator stopped ventilation and the alarm did not sound.The patient's oxygen saturation level temporarily decreased.The patient was placed on an ambu bag then placed on an alternate ventilator without injury.

Manufacturer Narrative

Correction to section h6 evaluation code method.H3: device evaluation summary: updated due to part return.Medtronic conducted an investigation based upon all information received.It was reported that while in use, this e360 ventilator had stopped ventilation and the alarm did not sound.The repair for the reported issue was performed by third party service provided (tkb _ tokibo).Third party service engineer was not able to reproduce the symptoms of stopped ventilation but found the display was not displayed and alarm did not raise as additional issue.By design an alarm is not expected incase of a faulty display.Third party service person replaced the display.A faulty display would appear to the user as to a loss of ventilation however a faulty display would not lead or cause a loss of ventilation.The ventilator would continue to deliver breaths as per the set patient settings.One lcd (liquid crystal display) was returned to medtronic for further analysis.The returned component was installed in the test unit and was powered on.Analysis found after post (power on self test) the ui (user interface) screen was not visible.The screen remained white and the soft keys were not visible after post.Further analysis found an unknown substance on the corner of uc1, however there was no damage or dent to the display.The investigation could not determine a cause of reported event of unit stopped ventilation however found faulty display as a secondary finding.The secondary finding is not related to the reported event.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.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.

• Brand Name: E360 VENTILATOR
• Type of Device: 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: 15402671
• MDR Text Key: 305258270
• Report Number: 2023050-2022-00027
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: E360E-JP-NA
• Device Catalogue Number: E360E-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 12/10/2022
• Supplement Dates FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1