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

Model Number	10049998
Medical Device Problem Codes	Failure to Calibrate (2440); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue identified during product analysis.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that the 840 ventilator generated an expir atory valve temperature out of range (oor) message and failed the flow sensor calibration.The device was available for evaluation.He service personnel (sp) inspected the ventilator, found the unit generated several background diagnostic codes and based on the codes, sp replaced the analog interface(ai) printed circuit board assembly(pcba).The unit passed all calibrations and tests as per the manufacturer's specifications at the time of service.One ai pcba was returned to medtronic for analysis.A visual inspection was carried out on the returned pcba, and no anomalies were observed.The ai pcba was attached to the test ventilator and powered up.The unit failed the analog devices test portion of power on self test(post) and reviewing the logs, it was observed that the unit generated several diagnostic codes indicating 'inspiratory pressure autozero offset failed' and 'expiratory pressure autozero offset failed'.Additionally, the unit failed multiple calibrations: flow sensor calibration, atmospheric pressure transducer calibration and exhalation valve calibration, confirming the ai pcba to be faulty.If a failure of the magnitude of the ai pcba occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient the cause of the reported event was isolated to a faulty ai pcba.The event is included in the 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.
Event or Problem Description
It was reported that this 840 ventilator generated an expiratory valve temperature out of range (oor) message and failed the flow sensor calibration. the ventilator was not in use on a patient at the time of the reported event.

• 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: 22464436
• Report Number: 8020893-2025-00136
• Device Sequence Number: 15477201
• Product Code: CBK
• UDI-Device Identifier: 10884521181045
• UDI-Public: (01)10884521181045(11)231120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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: 10049998
• Device Catalogue Number: 10049998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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