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

Model Number	E360
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	Hypoventilation (1916); No Code Available (3191)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was not delivering volume.Patient was removed from the ventilator and placed on an alternate ventilator with no harm reported.
Additional Manufacturer Narrative
Device evaluation: the service engineer evaluated the ventilator, found that the exhaled tidal volume was high and performed testing with calibrations.The ventilator passed all testing per manufacturing specification and was placed back into clinical use.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NEWPORT
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC; 1620 sunflower ave; costa mesa CA 92626
• MDR Report Key: 7736059
• Report Number: 2023050-2018-00046
• Device Sequence Number: 1041233
• Product Code: CBK
• UDI-Device Identifier: 10884521540989
• UDI-Public: 10884521540989
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E360
• Device Catalogue Number: E360E-WW-IN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/08/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0