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

Model Number E360

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the e360 ventilator had a flow sensor error.Patient involvement information was not provided by the customer.Covidien is not authorized to repair the device.A non-covidien service provider found the expiratory valve blocked.Cleaned the expiratory valve and verify all functions of the ventilator as per manufactures specification.Unit is working well.

• Brand Name: E360 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: ray maroofian ; 2101 faraday; calrsbad, CA 92008 ; 7606035334
• MDR Report Key: 6602546
• MDR Text Key: 76314393
• Report Number: 2023050-2017-05356
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K053502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2017

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
• Device Operator: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360T-SY-IN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2017
• Initial Date FDA Received: 05/31/2017
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1