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

Model Number	4-840220DIUA-EN
Medical Device Problem Codes	Defective Alarm (1014); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer, while in use on a patient, the actual tidal volume of this 840 ventilator was different from the set value and the ventilator did not alarm and the "exhalation loop" could not be closed.The patient was removed from the ventilator and placed on an alternate ventilator without injury.
Additional Manufacturer Narrative
Section e inital reporter from the facility could not be obtained due to age of reported event.H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported by the china food and drug administration (cfda), adverse reaction event center of shanghai, and not reported directly to medtronic by the customer, while in use on a patient, the actual tidal volume of this 840 ventilator was different from the set value and the ventilator did not alarm and the "exhalation loop" could not be closed.The ventilator was not made available to medtronic for evaluation.This issue was resolved by non-medtronic service personnel.The non-medtronic service personnel found that the oxygen (o2) flow sensor was damaged.The plausible cause of the "ventilator did not alarm" and "exhalation loop could not be closed" could be there being no violation of user settable alarm limits.The cause of the reported event of "tidal volume different from the set value" was isolated by non-medtroinc personnel to be a potential fault with the the o2 flow sensor.The events are 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: 21284865
• Report Number: 8020893-2025-00018
• Device Sequence Number: 9355789
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: 4-840220DIUA-EN
• Device Catalogue Number: 4-840220DIUA-EN
• 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: 01/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2011
• 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 Age: 54 YR
• Patient Sex: Male