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

Model Number	E360
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 the e360 ventilator's air sensor of the motherboard was defective.There was no patient involvement.The motherboard was replaced and a 5000k preventative maintenance (pm) was performed along with calibrations and all tests passed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEWPORT E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENTS, INC; 1620 sunflower avenue; costa mesa CA 92626
• MDR Report Key: 6600107
• Report Number: 2023050-2017-05345
• Device Sequence Number: 18851655
• Product Code: CBK
• UDI-Device Identifier: 10884521540958
• UDI-Public: 10884521540958
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K101803
• 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): 02/09/2017

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-RU-IN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2017
• Supplement Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1