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

Model Number	E360T
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 had lost the alternate current (ac) power supply and shutdown.The internal battery did not work after losing power.It was also reported that the patient experienced a desaturation in the oxygen level and was transferred to an alternate ventilator.The oxygen saturation was re-established with no reported patient harm.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COSTA MESA MFG DC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 8547251
• Report Number: 2023050-2019-00016
• Device Sequence Number: 2443261
• Product Code: CBK
• UDI-Device Identifier: 10884521541207
• UDI-Public: 10884521541207
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: E360T
• Device Catalogue Number: E360T-ES-NA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR