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 Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator generated a leak.Patient involvement information was not provided by the customer.Covidien /medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-covidien /medtronic service provider tightened the filters inside the ventilator and the issue was resolved.The ventilator worked normally.

• 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: 6635468
• Report Number: 2023050-2017-05459
• Device Sequence Number: 12256
• Product Code: CBK
• UDI-Device Identifier: 10884521540965
• UDI-Public: 10884521540965
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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-SY-IN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1