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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
Device Problem Low Battery (2584)
Patient Problem No Patient Involvement (2645)
Event Date 07/11/2017
Event Type  malfunction  
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 Description
It was reported that at a time of maintenance e360 ventilator generated a low battery alarm.There was no patient involvement reported at the time of event.
 
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Brand Name
E360 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave
costa mesa CA 92626
Manufacturer (Section G)
NEWPORT MEDICAL INSTRUMENTS, INC
1620 sunflower ave
costa mesa CA 92626
Manufacturer Contact
ray maroofian
2101 faraday ave
carlsbad, CA 92008
7606035334
MDR Report Key6798183
MDR Text Key82823746
Report Number2023050-2017-05706
Device Sequence Number1
Product Code CBK
UDI-Device Identifier10884521540941
UDI-Public10884521540941
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K053502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberE360
Device Catalogue NumberE360E-JP-NA
Was Device Available for Evaluation? No
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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