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	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator alarmed, generated diagnostic codes, safety valve opened, and ven tilation stopped.The patient was removed from the ventilator and was placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Patient information and initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.The device has been received and is under going investigation.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 updated to the evaluation date of the device section h6 evaluation codes updated due to the evaluation of the device method code - remove b21 and add b01 result code - remove c21 and add c13 conclusion code - remove d15 and add d02 component code - remove g07003 and add g04135 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 alarmed, generated diagnostic codes, the safety valve opened, and ventilation stopped.The device was available for evaluation.Service personnel (sp) inspected the unit, confirmed the reported issue in memory ,and replaced the air proportional solenoid (psol) due to leak.The unit passed all the required calibrations and tests as per manufacturer specifications at the time of service.The cause of the event was isolated to a potential fault in the psol.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 d9 updated to the return of a part section h6 evaluation codes updated due to the return and analysis of part method code, add additional code result code, add additional code component code, remove g04135 and add g0413501 h3 device evaluation summary: updated due to the return and analysis of a part medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, the 840 ventilators alarmed, generated diagnostic codes, the safety valve opened, and ventilation stopped.The device was available for evaluation.Service personnel (sp) inspected the unit, confirmed the reported issue in memory, and replaced the air proportional solenoid (psol) due to leak.The unit passed all the required calibrations and tests as per manufacturer specifications at the time of service.One psol was returned for further analysis: a visual inspection of the returned psol revealed no external anomalies.The psol was installed into a failure investigation test ventilator for analysis and the unit failed extended self test (est) for leak.A teardown of the psol was conducted and it was noted when the poppet was removed and a visual inspection under a microscope showed contamination of the concentric circles of the poppet which is the sealing ring.This contamination caused the poppet to stick and not function correctly.The cause of the event was isolated to a fault in the psol on air side 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: 19532266
• Report Number: 8020893-2024-00178
• Device Sequence Number: 18032485
• 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,Followup
• Report Date (Section B): 09/23/2024

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: 05/22/2024
• 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: 07/11/2024; 09/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/12/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2010
• 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