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

Model Number	10049998
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient, the 840 ventilator generated a background check breath delivery unit (bdu) alert indicating a bd electrically erasable programmable read only memory (eeprom) checksum error, which could lead to loss of ventilation.There was no reported patient injury.
Additional Manufacturer Narrative
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 generated a background check breath delivery unit (bdu) alert indicating a bd electrically erasable programmable read only memory (eeprom) checksum error, which could lead to loss of ventilation the ventilator was not made available to medtronic for evaluation.The distributor evaluated the unit and, based on the reported code, determined that the breath delivery (bd) central processing unit (cpu) printed circuit board (pcb) required replacement.Additional parts not associated with the event were also identified as needing replacement, including the graphical user interface handle and lock, as well as the power cord and its holder.With the information available, the cause of the event was isolated to a potential fault in bd cpu pcb.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; 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: 25479897
• Report Number: 8020893-2026-00100
• Device Sequence Number: 5443051
• Product Code: CBK
• UDI-Device Identifier: 10884521181045
• UDI-Public: (01)10884521181045(11)140415
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 05/14/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2014
• 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