MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	10049998
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter cannot be provided due to privacy regulations.Medtronic personnel reported event to manufacturer on beha lf of the customer.Section h4: estimated date of manufacture date h3.Medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the service engineer.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 an ¿autozero valve fault message with no audible alarm".The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Correction section g3 original report aware date should of been 09-may-2024 remove date of 10-may-2024 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 a, b5 and h4 updated h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this pb840 ventilator generated an ¿autozero valve fault message with no audible alarm".The "ventilation block associated with hemodynamic impact and finally turns down".The device was not available for evaluation.Failure confirmation, case, or relationship to the event could not be determined since no product was returned for evaluation or made available to medtronic.After good faith efforts the information about the failure and contributing cause could not be determined.Further action was not required, there is insufficient information about the failure and contributing cause.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received as follows: it was reported that while in use on a patient, this 840 ventilator generated an ¿autozero valve fault message with no audible alarm".The "ventilation block associated with hemodynamic impact and finally turns down".The patient had desaturation and hypotension.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.

• 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: 19473231
• Report Number: 8020893-2024-00171
• Device Sequence Number: 17152789
• Product Code: CBK
• UDI-Device Identifier: 10884521181045
• UDI-Public: 10884521181045
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 07/05/2024

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: 10049998
• Device Catalogue Number: 10049998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/20/2024; 06/10/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 06/25/2024; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male