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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 Codes No Patient Involvement (2645); No Information (3190)
Date of Event 05/23/2017
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the e360 ventilator had a leakage problem.Patient involvement information was not provided by the customer.The ventilator was evaluated by a third party service engineer and the customer reported issue was confirmed.The service engineer reconnected a loose oxygen hose and the issue was resolved.The ventilator worked normally.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Additional information was received that 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 Key6618635
Report Number2023050-2017-05419
Device Sequence Number16146385
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,Followup
Report Date (Section B) 10/30/2017
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
Initial Date Received by Manufacturer 05/23/2017
Supplement Date Received by Manufacturer05/31/2017
Initial Report FDA Received Date06/07/2017
Supplement Report FDA Received Date10/30/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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