MAUDE Adverse Event Report: COSTA MESA MFG DC E360 VENTILATOR; 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	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the water trap filter was returned for further product analysis.External visual inspection revealed a few cracks in the water trap.The water trap was then connected to the test unit with an oxygen resource and investigated.It was noticed that the water trap was leaking oxygen, confirming the customer complaint.The cause of the failure was a crack in the water trap filter, leading to leakage.Complaint trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when oxygen to the e360 ventilator was provided, the unit is leaked air at inlet water trap inside inlet oxygen.There was no patient involvement.
Additional Manufacturer Narrative
The initial regulatory report was submitted under e2017032.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): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7383409
• Report Number: 2023050-2018-00018
• Device Sequence Number: 1426576
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1