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

Model Number	E360E-CN-NA
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer that while in use on a patient, the screen of this 840 ventilator had "frozen", parameters could not be adjusted, respiratory waveform remained unchanged, but device did not issue any alarms.The patient was removed from the ventilator and was placed in an alternate ventilator without injury.
Additional Manufacturer Narrative
H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Section b5 updated section d4 unique identifier (udi): updated section h6 evaluation codes were updated due to customer evaluation of the device.Method code (annex b) remove b17 and add b13 result code (annex c)remove c20 and add c13 h3 it was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer that while in use on a patient, the screen of this e360 ventilator had "frozen", parameters could not be adjusted, respiratory waveform remained unchanged, but device did not issue any alarms.The ventilator was not made available to medtronic for evaluation.It was reported that the customer ¿conducted maintenance and ventilator was returned to normal¿.Though requested, specific evaluation details were not provided.With the information available, the investigation could not confirm the reported event or determine the potential cause due to insufficient information.The event is included in a data monitoring plan.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Update: it was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer that while in use on a patient, the screen of this e360 ventilator had "frozen", parameters could not be adjusted, respiratory waveform remained unchanged, but device did not issue any alarms.The patient was removed from the ventilator and was placed in 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23658351
• Report Number: 2023050-2025-00043
• Device Sequence Number: 13292801
• Product Code: CBK
• UDI-Device Identifier: 10884521540910
• UDI-Public: (01)10884521540910(11)160513
• 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,Followup
• Report Date (Section B): 03/05/2026

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: E360E-CN-NA
• Device Catalogue Number: E360E-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: 11/05/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2016
• 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: 84 YR
• Patient Sex: Male