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

Model Number	E360
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the e360 ventilator sparks.There was no patient involvement.
Additional Manufacturer Narrative
Correction to initial report date mfg rec should have been reported as 2017-10-19.If information is provided in the future, a supplemental report will be issued.

• 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: 6965656
• Report Number: 2023050-2017-05791
• Device Sequence Number: 13840378
• 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): 10/24/2017

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
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 10/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1