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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 High Readings (2459)
Health Effect - Clinical Codes No Patient Involvement (2645); No Information (3190)
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the e360 ventilator oxygen was high.Patient involvement information was not provided by the customer.Covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The ventilator was not in use on a patient at the time of the reported event.
 
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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 Key6639755
Report Number2023050-2017-05466
Device Sequence Number16382248
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,Followup
Report Date (Section B) 11/07/2017
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
Initial Date Received by Manufacturer 06/02/2017
Supplement Date Received by Manufacturer11/06/2017
Initial Report FDA Received Date06/14/2017
Supplement Report FDA Received Date11/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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