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	11/27/2025
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 received the suspect device and is under evaluation.Review of ventilator 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, this 840 ventilator generated diagnostic codes which indicated air proportional solenoid valve (psol) stuck open and loss of breath delivery (bd) communication, and ventilation stopped.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section h3 updated due to device evaluation.Section h6 evaluation codes were updated due to evaluation of returned device method code (annex b) remove b21 and add b01 result code (annex c) remove c21 and add c07, c13 conclusion code (annex d) remove d16 and add d02 component code (annex g) remove g07003 and add g04135 h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that while in use on a patient, this 840 ventilator generated diagnostic codes which indicated air proportional solenoid valve (psol) stuck open and loss of breath delivery (bd) communication, and ventilation stopped.The device was available for evaluation.Review of ventilator logs confirmed loss of ventilation.The service personnel (sp) inspected the unit and confirmed the reported issue and replaced the psol.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One psol was returned to medtronic for analysis.A visual inspection of the returned psol revealed no external anomalies.The psol was installed into a failure investigation test ventilator for analysis.The unit powered up normally and no errors were recorded in the diagnostic logs.The ventilator failed the extended self test (est) for psol leak.A teardown of the psol was conducted, and a visual inspection under a microscope showed contamination of the concentric circles of the poppet sealing ring.The cause of the event was isolated to a faulty 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; michael collins rd mervue; galway ; EI
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway ; EI
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23878806
• Report Number: 8020893-2025-00278
• Device Sequence Number: 9650284
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: (01)10884521076891(11)170504
• 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): 04/14/2026

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
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• 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