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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 Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Patient Involvement (2645)
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 generated a oxygen supply loss alarm.There was no patient involvement at the time of the reported condition.Covidien/medtronic was not authorized to evaluate/service the device so the reported complaint could not be confirmed.A non-covidien /medtronic service provider checked the ventilator and found reported problem.The service provider crosschecked servo valve with working ventilator and confirmed it was determined that the servo valve needs to be replaced.
 
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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 Key6648935
Report Number2023050-2017-05485
Device Sequence Number1049124
Product Code CBK
UDI-Device Identifier10884521541122
UDI-Public10884521541122
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) 06/06/2017
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 NumberE360S-WW-IN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2017
Initial Report FDA Received Date06/16/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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