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

Model Number	E360
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2017
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 the e360 ventilator had a leak.The ventilator was not in use on a patient at the time of the reported event.Medtronic was not authorized to evaluate/repair the device as the product is not in medtronic control.The repair was completed at a non-medtronic location and the service engineer (se) confirmed the leak and replaced the water trap.The issue was corrected.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
A water trap bowl was returned to covidien/medtronic¿s product analysis.A visual inspection of the returned component was performed and cracks were found on the bottom of the bowl.An investigation was performed and the product analysis technician reported that the reported issue was verified.The root cause was isolated to the manual drain was over-torqued causing cracks at the bottom of the bowl.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: 6726333
• Report Number: 2023050-2017-05545
• Device Sequence Number: 1039832
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2017

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: 08/25/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1