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

Model Number	E360
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the device/component from the customer for evaluation nor has a medtronic engineer evaluated the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during use on patient, the e360 ventilator generated an alarm, a communication error message was displayed, ventilation stopped and there was a power off issue.The patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.Later, a hospital medical device engineer inspected the device and confirmed that there was a "no communications" error recorded in the ventilator logs.Additionally it was noted that the ventilator's time was 12 hours ahead.There was no power off issue recorded in the event history.

• 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: 8287233
• Report Number: 2023050-2019-00001
• Device Sequence Number: 2056107
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1