MAUDE Adverse Event Report: NEWPORT MEDICAL INSTRUMENT, INC. E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360T-SY-IN
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that smoke was seen from the e360 ventila tor's compressor capacitor and the compressor was not working.The device was made available for evaluation.The service personnel (sp) inspected the ventilator and reported that the auto drain filter and the alternating current (ac) capacitor need replaced.From the images received, thermal damage on the capacitor was observed.The likely cause of the event was isolated in the field to a potential fault in the ac capacitor.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that smoke was seen from the e360 ventilator's compressor capacitor and the compressor was not working.The ventilator was not in use on a patient at the time of the event.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 12421304
• Report Number: 2023050-2021-00024
• Device Sequence Number: 17059248
• Product Code: CBK
• UDI-Device Identifier: 10884521510807
• UDI-Public: 10884521510807
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: Other
• Device Model Number: E360T-SY-IN
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1