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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 Codes Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code No Information (3190)
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 360 ventilator had an oxygen leak.Patient involvement information was not provided by the customer.Covidi en/medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-covidien /medtronic service provider reconnected the tubes to the oxygen sensor filter and the issue was resolved.The ventilator was tested and checked to be running normally.
 
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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 Key6625022
Report Number2023050-2017-05446
Device Sequence Number105806
Product Code CBK
UDI-Device Identifier10884521540965
UDI-Public10884521540965
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K053502
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/29/2017
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 NumberE360E-SY-IN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/29/2017
Initial Report FDA Received Date06/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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