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	01/18/2026
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 service engineer.A review of the logs confirmed loss of ventilation.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 diagnostic code indicating bad breath delivery (bd) 12 volts supply and ventilation stopped.The patient was removed from the ventilator and was placed in an alternate ventilator.The patient then passed away due to an underlying disease, and the death was not causally related to this incident.
Additional Manufacturer Narrative
Section d9 updated due to device evaluation.Section h3 updated due to device evaluation.Section h6 evaluation codes updated due to device evaluation.Method code (annex b), additional code added.Result code (annex c), removed c21 and added c13.Conclusion code (annex d), removed d16 and added d02.Component code (annex g), removed g07003 and added g02005.H3 device evaluation summary: it was reported that while in use on a patient, the 840 ventilator generated a background check alert diagnostic code indicating "bad breath delivery (bd) 12 volts supply" and ventilation stopped.Review of the ventilator logs confirmed the reported loss of ventilation (lov).The service personnel (sp) inspected the unit and confirmed the reported issue with the codes in the logs, but could not duplicate.Based on the codes, sp replaced the analog interface (ai) printed circuit board (pcb).Additionally, sp replaced the real-time clocks on the graphical user interface (gui) and breath delivery (bd) central processing unit (cpu) printed circuit board (pcb).The ventilator passed all calibrations and tests as per manufacturer specifications at the time of service.The cause of the reported event was isolated to a potential fault in the analog interface (ai) printed circuit board (pcb).The real time clocks have an internal battery so the date and time can be maintained while the ventilator is unplugged, therefore it is likely the cause of the issue with them was a depleted battery.The events are 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24309002
• Report Number: 8020893-2026-00016
• Device Sequence Number: 18561745
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: (01)10884521076891(11)110211
• 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): 03/25/2026

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: 01/19/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2011
• 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