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

Model Number	10049998
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during preventative maintenance by the customer, this 840 ventilator failed the battery test during the extended self-test (est).After changing the battery pack, plugging the power supply back in, and turned on, the device continuously alarmed, the screen went black, and smoke came out of the unit.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that, during preventative maintenance by the customer, this 840 ventilator failed the battery test during the extended self-test (est).After changing the battery pack, plugging the power supply back in, and turned on, the device continuously alarmed, the screen went black, and smoke came out of the unit the device was available for evaluation.It was reported that the customer's biomedical engineer performed preventive maintenance and installed a third-party battery since the unit failed then battery test during the extended self-test (est).The service personnel (sp) inspected the ventilator was unable to power unit on to retrieve logs.The battery was removed from the ventilator.Sp found that the inspiratory flow module (ifm) was burnt and damaged by smoke.The customer did not authorize repair.The likely cause of the event was isolated in the field to a potential fault in the ifm.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality 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.
Additional Manufacturer Narrative
H3 device evaluation summary: updated due to image received on 22-dec-2022.Medtronic conducted an investigation based upon all information received.It was reported that, during preventative maintenance by the customer, this 840 ventilator failed the battery test during the extended self-test (est).After changing the battery pack, plugging the power supply back in, and turned on, the device continuously alarmed, the screen went black, and smoke came out of the unit the device was available for evaluation.It was reported that the customer's biomedical engineer performed preventive maintenance and installed a third-party battery since the unit failed then battery test during the extended self-test (est).The service personnel (sp) inspected the ventilator was unable to power unit on to retrieve logs.The battery was removed from the ventilator.Sp found that the inspiratory flow module (ifm) was burnt and damaged by smoke.Analysis of an image provided also confirms the signs of smoke damage.The unit is recommended not to use and awaiting the customer's approval to repair.The likely cause of the event was isolated in the field to a potential fault in the ifm.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality 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 ; EI
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16070360
• Report Number: 8020893-2022-00321
• Device Sequence Number: 20402127
• Product Code: CBK
• UDI-Device Identifier: 10884521181045
• UDI-Public: 10884521181045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2023

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: 10049998
• Device Catalogue Number: 10049998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 01/15/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2016
• 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 Sex: Unknown