MAUDE Adverse Event Report: COSTA MESA MFG DC NEWPORT; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial regulatory report was submitted under retrospective summary report e2017032.Device evaluation summary: the service provider swapped the two inlet water traps one water trap was returned for failure analysis.The reported symptom was verified.The water trap was connected to the air line of a test e360 ventilator.The water trap was connected to an air source.A leak in the water trap assembly was confirmed.Upon further inspection of the water trap assembly, a metal bushing between the bowl and the valve body was in the incorrect orientation, causing the collar not to fully thread.The nut securing the drain to the bottom of the bowl was also askew, causing a gap.Additionally there was an extra o-ring (2 o-rings instead of 1) between the drain and the bottom of the inside of the water trap bowl.According to the part's service and installation instructions there should only be one o-ring between the drain and the inside of the water trap bowl.The bowl guard was placed in the correct orientation, the nut securing the drain was properly fastened, and the extra o-ring was removed.The reported symptom was caused by an improper assembly of the water trap.The root cause of the improper ass embly is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when providing oxygen to the e360 ventilator, the unit leaked air at inlet water trap inside inlet oxygen.There was no patient involvement.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7441280
• Report Number: 2023050-2018-00024
• Device Sequence Number: 1144287
• Product Code: CBK
• UDI-Device Identifier: 10884521540965
• UDI-Public: 10884521540965
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360E-SY-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1