Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NEWPORT MEDICAL INSTRUMENTS, INC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number E360
Medical Device Problem Code Sparking (2595)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 10/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Medtronic was not authorized to evaluate/repair the device as the product is not in medtronic control.The repair was completed at a non-medtronic location and the service provider (sp) adjusted the settings.The reported complaint could not be confirmed without the product return.Should new information become available the complaint will be re-evaluated.
 
Event or Problem Description
It was reported that the e360 ventilator had sparking problem.The ventilator was not in use on a patient at the time of the reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6962631
Report Number2023050-2017-05790
Device Sequence Number1221794
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 company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/19/2017
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/12/2017
Initial Report FDA Received Date10/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-