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

Model Number	E360S-CN-NA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2019
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.The engineer from a third-party maintenance company inspected the ventilator.The machine was restarted, and there was no abnormality after the repeated restarts.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient this e360 ventilator generated an alarm and power disconnected message, the ventilator stopped delivering breaths to the patient and automatically shuts down.The patient was transferred to an alternate ventilator without injury.
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.The engineer from a third-party maintenance company inspected the ventilator.The machine was restarted, and there was no abnormality after the repeated restarts.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a patient this e360 ventilator generated an alarm and power disconnected message, the ventilator stopped delivering breaths to the patient and automatically shuts down.The patient was transferred to an alternate ventilator without injury.

• Brand Name: E360 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer (Section G): NEWPORT MEDICAL INSTRUMENT, INC.; 1620 sunflower ave; costa mesa CA 92626
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 13193699
• Report Number: 2023050-2022-00001
• Device Sequence Number: 4404602
• Product Code: CBK
• UDI-Device Identifier: 10884521541078
• UDI-Public: 10884521541078
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K101803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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: E360S-CN-NA
• Device Catalogue Number: E360S-CN-NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic