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

Model Number E360

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2019

Event Type  malfunction  

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 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
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 8418713
• MDR Text Key: 138768935
• Report Number: 2023050-2019-00011
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K101803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1