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

Model Number	E360
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
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 a e360 ventilator would not turn on.Patient involvement information was not provided by the customer.

• 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: 6553707
• Report Number: 2023050-2017-05271
• Device Sequence Number: 16318244
• 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
• Report Date (Section B): 04/12/2017

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: 04/12/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1