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

Model Number	E360
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on a patient the e360 ventilator's gui (graphic user interface) went blank with an alarm and stopped ventilation.It was also noted that the device emitted a burnt smell.The patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.
Additional Manufacturer Narrative
Correction to section h6.Evaluation code method, result and conclusion.Device evaluation summary: one display board and one display cable were returned to medtronic for further analysis.A visual inspection was conducted on the display board as well as the cable, observed that the cmos octal latch with 3-state output (u2) had thermal damage and a small portion of the insulation was melted respectively.The display cable lies in front of the display board, indicating that the cable may have come into contact with the ic during the thermal event.U2 relays signals between the main micro-controller and the program memory (4kb eprom).The reported symptom was caused by u2 experiencing a thermal event.However, the cause of the thermal event could not be determined, so the root cause could not be determined.The likely cause of the event was isolated to faulty component u2 due to thermal damage, but cause of the thermal damage could not be determined.The event will be included in trending and monitoring.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
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9079762
• Report Number: 2023050-2019-00040
• Device Sequence Number: 14079349
• Product Code: CBK
• UDI-Device Identifier: 10884521540941
• UDI-Public: 10884521540941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: E360
• Device Catalogue Number: E360E-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1