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

Model Number	E360
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator oxygen supply was lost and had leaking noise.Patient involvement is unknown.Medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-medtronic service provider checked the ventilator and verified the problem.
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 oxygen supply was lost and had leaking noise.The ventilator was not in use on a patient at the time of the reported event.Medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-medtronic service provider checked the ventilator and verified that a disconnected tubing causing the noise.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; costa mesa
• MDR Report Key: 6603921
• Report Number: 2023050-2017-05364
• Device Sequence Number: 16283158
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2017

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): FDA Requested
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1