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

Model Number	4-840220DIPC-PL
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this 840 ventilator had a power supply issue, burning smell and emitted smoke.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this 840 ventilator had a power supply issue, burning smell and emitted smoke.The device was available for evaluation.The service personnel (sp) inspected the ventilator, found visual damage on the breath delivery (bd) module and replaced the breath delivery unit (bdu) central processing unit (cpu) printed circuit board (pcb), the power supply, the motherboard pcb, and analog interface (ai) printed circuit board (pcb).The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.The cause of the reported issue was isolated in the field to a potential fault in bdu cpu pcb and/or the power supply and/or motherboard pcb and/or ai pcb.Further action was not required because 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; michael collins rd mervue; galway,ie
• Manufacturer (Section G): COVIDIEN; michael collins rd mervue; galway,ie
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22533004
• Report Number: 8020893-2025-00148
• Device Sequence Number: 7931812
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: (01)10884521077096(17)500101
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 07/17/2025

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: 4-840220DIPC-PL
• Device Catalogue Number: 4-840220DIPC-PL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2000
• 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