MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during the battery drive test, the e360 ventilator shut down.There was no patient involvement at the time of the event.It was reported that the battery needed to be replaced.Medtronic/covidien was not authorized to evaluate/repair the device as the product is not in medtronic/covidien control.The repair will be completed at a non-medtronic/covidien location.The reported complaint could not be confirmed without the product return.Should new information become available or if the product is returned to the manufacturer for investigation the complaint will be re-evaluated.
Additional Manufacturer Narrative
Device evaluation summary: one battery pack assembly was returned to medtronic for further analysis.Battery was tested on uba battery analyzer and it failed the 10-hour discharge portion of testing, lasting only three and a half hours.Date on the battery showed tested 01/30/15.The cause of the observed condition was determined to be the expired battery.No corrective actions were taken since the event included in monitoring.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): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 6753913
• Report Number: 2023050-2017-05591
• Device Sequence Number: 162691
• Product Code: CBK
• UDI-Device Identifier: 10884521540941
• UDI-Public: 10884521540941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: E360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 07/04/2017
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1