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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR CONTINUOUS VENTILATOR

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NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR CONTINUOUS VENTILATOR Back to Search Results
Model Number E360
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
Event Date 01/22/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Covidien was not authorized to evaluate/service the device so the reported complaint could not be confirmed.
 
Event Description
It was reported that the e360 ventilator battery was replaced according to the 2 years replacement term, however the battery did not last 2 years. There was no patient involvement.
 
Manufacturer Narrative
(b)(4). The service engineer inspected the device an replaced the battery. The ventilator was returned to use.
 
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Brand NameE360 VENTILATOR
Type of DeviceCONTINUOUS VENTILATOR
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 Key6332976
MDR Text Key67716896
Report Number2023050-2017-00142
Device Sequence Number1
Product Code CBK
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
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE360
Device Catalogue NumberE360E-JP-NA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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