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

Model Number E360E-CN-NA

Device Problem Defective Alarm (1014)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/09/2022

Event Type  malfunction  

Event Description

It was reported that while in use on a patient, the e360 ventilator was not delivering air, and the unit had neither alarm sound or light.It was also reported that the saturation concentration of blood oxygen of the patient decreased.Although requested, the information regarding patient intervention was not provided.The patient was not harmed or injured as a result of the reported event.

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.It was reported that while in use on a patient, the e360e ventilator was not delivering air, and the unit had neither alarm sound or light.Medtronic received complaint from the adverse reaction event center of shanghai, rather than reported directly to medtronic by the customer.The current status of the product was unknown and could not be returned.Specifications could not be determined.Failure confirmation, root cause, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.After good faith efforts there is insufficient information about the failure and contributing cause.T the service history review (shr) of the ventilator is not available.The serial number indicates the ventilator is more than 2 years old.There is not enough information available to determine if any relationship to a manufacturing fault.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: E360 VENTILATOR
• Type of Device: 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; carslbad, CA 92008 ; 7606035046
• MDR Report Key: 15108629
• MDR Text Key: 304620938
• Report Number: 2023050-2022-00021
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521540910
• UDI-Public: 10884521540910
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K101803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2022

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
• Device Operator: 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
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Male