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

Model Number	E360
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator had air leakage, generating a noise.At this time, it is unknown if there was patient involvement.Medtronic/covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-medtronic/covidien service provider checked the ventilator and found the air leakage due to loose tubing.To address the issue, the tube was connected properly.The ventilator was working satisfactorily.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The ventilator was not in use on a patient at the time of the reported event.

• 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: 6683078
• Report Number: 2023050-2017-05516
• Device Sequence Number: 10809904
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2017

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: E360
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 06/13/2017; 11/30/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/07/2017; 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1