MAUDE Adverse Event Report: COSTA MESA MFG DC E360 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	E360
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the service engineer evaluated the device but he could not confirm the root cause for the event.If the device is returned for failure investigation, a supplement med watch 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, while in standby mode, the e360 ventilator was found burnt.The ventilator was not in use on a patient at the time of the reported event. .
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the e360 ventilator was burnt while it was in standby mode.The ventilator was not in use on a patient at the time of the reported event.Additionally, the device had flames and smoke at the time of reported event.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7899642
• Report Number: 2023050-2018-00066
• Device Sequence Number: 1395092
• Product Code: CBK
• UDI-Device Identifier: 10884521541283
• UDI-Public: 10884521541283
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: E360T-SY-IN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 09/21/2018
• 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