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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 Problems Premature Discharge of Battery (1057); Failure to Charge (1085)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was replaced. Covidien was not authorized to evaluate/repair the device.
 
Event Description
It was reported that during use the e360 ventilator battery indicator showed only 2 bars from the first. The patient was transferred to a different ventilator. There was no patient harm/injury reported as a result of this event.
 
Manufacturer Narrative
(b)(4). The service engineer (se) inspected the device and verified the reported issue. The se replaced the battery and 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
kelly adams
2101 faraday avenue
carlsbad, CA 92008
7606035046
MDR Report Key6205117
MDR Text Key63305692
Report Number2023050-2016-00791
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K101803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberE360
Device Catalogue NumberE360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Yes
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 Treatment Data
Date Received: 12/27/2016 Patient Sequence Number: 1
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