MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	4-840120DIUU-US
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: medtronic (b)(4) has received the suspect device/component from the customer for evaluation at the (b)(6) service center, but the device is yet to be 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 smoke emitted from this 840 ventilator's power supply.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Component code added.Correction to section h6 evaluation code method and result.Medtronic conducted an investigation based upon all information received.It was reported that smoke emitted from this 840 ventilator's power supply.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirm the reported event but repairs were not performed.Customer to discard the unit.The cause of the observed condition could not be determined.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s specifications.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: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins rd mervue; galway,ie ; EI
• MDR Report Key: 12188507
• Report Number: 8020893-2021-00104
• Device Sequence Number: 14212025
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 4-840120DIUU-US
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1