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	02/21/2025
Type of Reportable Event	Malfunction
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: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.A review of the ventilator logs confirm the reported psol stuck open code which would lead to a loss of ventilation to the patient.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
It was reported that while in use on a patient, the 840 ventilator generated a background check alert message indicating air proportional solenoid (psol) stuck open.The patient was removed from the ventilator and was placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section d9 was updated due to device evaluation section h6 evaluation codes were updated due to device evaluation method code (annex b) additional code added result code (annex c) remove c20 and add c13 conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g07003 and add g07001 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 a background check alert message indicating air proportional solenoid (psol) stuck open.The device was available for evaluation.Based on the review of the logs, it was confirmed that the ventilator generated a diagnostic code indicating an open air psol stuck event that would lead to loss of ventilation.The service personnel (sp) inspected the ventilator, confirmed the reported issue with a background diagnostic code in the logs but could not replicate.Based on the code, sp replaced air proportional solenoid (psol) and inspiratory electronics printed circuit board (pcb).Additionally, sp replaced breath delivery (bd) central processing unit (cpu) printed circuit board (pcb) as a preventative measure.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to potential fault in air psol and/or inspiratory electronics pcb and/or bd cpu pcb.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.
Additional Manufacturer Narrative
Section d4 unique identifier (udi)# updated section d9 was updated due to returned parts section h6 evaluation codes were updated due to analysis of returned parts.Conclusion code (annex d) remove d02 and add d15 h3 device evaluation summary: was updated due to analysis of returned parts medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the 840 v entilator generated a background check alert message indicating air proportional solenoid (psol) stuck open.The device was available for evaluation.Based on the review of the logs, it was confirmed that the ventilator generated a diagnostic code indicating an open air psol stuck event that would lead to loss of ventilation.The service personnel (sp) inspected the ventilator, confirmed the reported issue with a background diagnostic code in the logs but could not replicate.Based on the code, sp replaced air proportional solenoid valve (psol) and inspiratory electronics printed circuit board (pcb).Additionally, sp replaced breath delivery (bd) central processing unit (cpu) printed circuit board (pcb) as a preventative measure.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The air psol valve, inspiratory electronics pcb and bd cpu pcb were returned to medtronic for analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.The potential cause may be due to a temporary difference between the expected air flow and that produced by proportional solenoid valve (psol).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.

• 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: 21637010
• Report Number: 8020893-2025-00053
• Device Sequence Number: 9246283
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: (01)10884521076891(11)071017(21)3510074115
• 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,Followup
• Report Date (Section B): 08/13/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 08/06/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/16/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2007
• 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