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

Model Number	E360E-CN-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while in use on a patient, a ventilator shut down unexpectedly, had no display and was not ventilating.The patient was removed from the ventilator with no harm or injury.
Event or Problem Description
It was reported that while in use on a patient, an e360 ventilator shut down unexpectedly, had no display and was not ventilating.The patient was removed from the ventilator with no harm or injury.
Additional Manufacturer Narrative
Corrections: h3: code 81- medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.Device evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned for evaluation.It was reported that an e360 ventilator shut down unexpectedly, had no display and was not ventilating.An associated device issue could not be confirmed.No root cause was identified, since no product was returned.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that the product has met all medtronic quality specifications.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: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 9640163
• Report Number: 2023050-2020-00004
• Device Sequence Number: 11455187
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

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
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR