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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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
The initial regulatory report was submitted under rsr e2017032.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.
 
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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 Key7383478
Report Number2023050-2018-00019
Device Sequence Number1543321
Product Code CBK
UDI-Device Identifier10884521541283
UDI-Public10884521541283
Combination Product (Y/N)N
Initial Reporter CountryVM
PMA/510(K) Number
K101803
Number of Events Summarized1
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) 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 NumberE360
Device Catalogue NumberE360T-SY-IN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/27/2018
Initial Report FDA Received Date03/29/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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