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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient, the 840 ventilator generated an alarm indicating that the ventilation stopped with di agnostic code.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.A review of the logs confirmed that the ventilator stopped 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.
Additional Manufacturer Narrative
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
Correction d4 unique identifier (udi)# section h6 evaluation codes were updated due to device evaluation.Method code (annex b) remove b21 and add b01 result code (annex c) remove c21 and add c13 conclusion code (annex d) remove d16 and add d02 component code (annex g) remove g07003 and add g02005 h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that during use on a patient, the 840 ventilator generated an alarm indicating that the ventilation stopped with multiple diagnostic codes.The device was available for evaluation.A review of the logs confirmed that the ventilator stopped ventilation.The service personnel (sp) inspected the ventilator, found multiple background diagnostic codes in the logs and based on the code sp replaced the analog interface (ai) printed circuit board (pcb).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 ai 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 d9 was updated due to part return section h6 evaluation codes were updated due to analysis of part returned conclusion code (annex d) remove d02 and add d15 component code (annex g) remove g02005 and add g07001 h3 device evaluation summary: was updated due to analysis of part returned medtronic conducted an investigation based on all information received.It was reported that during use on a patient, the 840 ventilator generated an alarm indicating that the ventilation stopped with multiple diagnostic codes.The device was available for evaluation.A review of the logs confirmed that the ventilator stopped ventilation.The service personnel (sp) inspected the ventilator, found multiple background diagnostic codes in the logs and based on the codes sp replaced the analog interface (ai) printed circuit board (pcb).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The ai pcb was returned to medtronic for analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.Since the ai pcb returned and tested satisfactorily a cause of the event could not be established.A potential cause of the reported event was a transient communication issue with the ai pcb or associated connections which was resolved when the pcb was removed.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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23065011
• Report Number: 8020893-2025-00218
• Device Sequence Number: 9850274
• Product Code: CBK
• UDI-Device Identifier: 10884521076891
• UDI-Public: (01)10884521076891(11)170323
• 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,Followup
• Report Date (Section B): 01/15/2026

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: 08/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 10/10/2025; 01/13/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/20/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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