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

Model Number	E360
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator had incompatible display board software and does not accept any command.Patient involvement information was not provided by the customer.Medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.The ventilator was evaluated and it was reported that the single board computer and its connections were cleaned.The ventilator is in working condition.

• 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: 6541252
• Report Number: 2023050-2017-05242
• Device Sequence Number: 10796510
• Product Code: CBK
• UDI-Device Identifier: 10884521541122
• UDI-Public: 10884521541122
• 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): 04/05/2017

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: E360S-WW-IN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1