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

Model Number	E360
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Inoperable (1663)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien/medtronic has not received the device/component from the customer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on a patient the e360 ventilator generated a continuous alarm, the display monitor was blocked out, ventilation stopped and there was a burnt smell.The patient was removed from the ventilator and placed on an alternate ventilator with no patient harm reported.
Additional Manufacturer Narrative
Device evaluation summary: the returned main board was not installed into the test unit due to thermal damage.The main board was examined and c10 (capacitor 100 micro farad) was found open.The capacitor is part of the circuit that connects to pin 16 on connector j2.The connector j2 connects to the direct current (dc) to dc power supply board.The cause of the thermal damage could not be determined.If information is provided in the future, a supplemental report will be issued.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MRDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7426985
• Report Number: 2023050-2018-00022
• Device Sequence Number: 1717028
• Product Code: CBK
• UDI-Device Identifier: 10884521540941
• UDI-Public: 10884521540941
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/21/2019

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: E360E-JP-NA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1