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

Model Number	E360
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medtronic field service engineer evaluated the device and replaced the loud speakers.The ventilator passed all testing per manufacturing specification and was returned to the customer.If the replaced part is returned for failure investigation, a supplement medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during servicing, the e360 ventilator failed calibration and found the device had no audible alarm with the faulty loudspeakers.The ventilator was not in use on a patient at the time of the reported 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: 8418713
• Report Number: 2023050-2019-00011
• Device Sequence Number: 1465947
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• 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): 03/13/2019

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 Number: E360
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1