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

Model Number	4-840120DIJJ-JP
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator generated an "abnormal" alarm and the ventilation stopped.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e.Japan medtronic personnel reported event to manufacturer on behalf of the customer.H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the 840 ventilator generated an "abnormal" alarm and the ventilation stopped.The device was available for evaluation.The service personnel inspected the ventilator, confirmed the reported event by relevant code in the ventilator logs, and replaced the proportional solenoid (psol) valve.The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.The cause of the reported event was isolated to a potential fault in the psol valve.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a trending and 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.
Additional Manufacturer Narrative
Section was updated due to a part return.Section evaluatin codes were updated due to analysis of part returned conclusion code remove d02 and add d15 component code remove g0413501 and add g07001.Device evaluation summary was updated due to analysis of part returned: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the 840 v entilator generated an "abnormal" alarm and the ventilation stopped.The device was available for evaluation.The service personnel inspected the ventilator, confirmed the reported event by relevant code in the ventilator logs, and replaced the proportional solenoid (psol) valve.The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.The psol valve was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.The replaced component did address the issue in the field however, the returned component psol valve was analyzed and tested satisfactorily.With the information available a likely cause 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 specifications.The event is included in a trending and 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.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway ; EI
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19542660
• Report Number: 8020893-2024-00180
• Device Sequence Number: 12656319
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: 10884521076891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 4-840120DIJJ-JP
• Device Catalogue Number: 4-840120DIJJ-JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2007
• 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