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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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NEWPORT MEDICAL INSTRUMENTS, INC 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 07/18/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the e360 ventilator oxygen (o2) water trap/filter was leaking when connected to the o2 source.The ventilator was not in use on a patient at the time of the reported event.A service engineer (se) inspected the device and replaced the o2 water trap assembly.The unit passed all testing and operated within the manufacturing specifications.
 
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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 Key6818855
Report Number2023050-2017-05768
Device Sequence Number18864610
Product Code CBK
UDI-Device Identifier10884521540910
UDI-Public10884521540910
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K053502
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/26/2017
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 NumberE360
Device Catalogue NumberE360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2017
Initial Report FDA Received Date08/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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