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

Model Number	E360
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	07/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator had a setting issue.Although requested, information pertaining to the use of the device at the time of the reported event and patient outcome (if applicable) has not been provided.Medtronic was not authorized to evaluate/repair the device as the product is not in medtronic control.The repair will be completed at a non-medtronic 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
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the e360 ventilator has a setting issue, the oxygen (o2) is not setting on the vent.The ventilator was not in use on a patient at the time of the reported event.A service provider verified the reported issue: o2 displaying is too low as compared to the set value.The service provider performed o2 sensor calibration and the issue was resolved.The ventilator was tested and checked to be running 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: 6785838
• Report Number: 2023050-2017-05656
• Device Sequence Number: 1565871
• Product Code: CBK
• UDI-Device Identifier: 10884521510807
• UDI-Public: 10884521510807
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: E360T-SY-IN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1