MAUDE Adverse Event Report: COVIDIEN 980 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	980X3ENDIUU
Medical Device Problem Codes	Improper Flow or Infusion (2954); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue identified during product analysis.H3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that while in use on a patient, the 980 ventilator generated a message indicating that a short self test (sst) was required.The device was available for evaluation.A review of the ventilator logs indicates the ventilator entered into backup ventilation at the time of the event and, subsequent to the patient being removed from the ventilator, the extended self test (est) failed.Service personnel (sp) inspected the unit, found the safety valve was open, and reviewed logs and found the expiratory pressure autozero offset failure message.During troubleshooting, the extended self test (est) failed, and sp replaced the exhalation valve assembly (eva) and exhalation module cable.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.Although reported sst was required, a review of the logs indicates ¿est was required¿.The ventilator was in this state due to the previously detected expiratory pressure autozero offset failure, also recorded in the logs.One exhalation module cable was returned to medtronic for analysis.The returned component was visually inspected and functionally tested with no malfunction or product deficiency observed.One eva was returned to medtronic for analysis.Visual inspection of the returned eva found no anomalies.The eva was attached to the failure investigation test ventilator for analysis.During testing, calibrations failed with the onscreen message "exp pressure autozero offset failed".On further inspection, it was found that the pressure sensor ps1 on the exhalation sensor printed circuit board assembly (pcba) of the eva was faulty.If a failure of the ps1 occurs while in use on a patient, the ventilator response would be backup ventilation (buv) to the patient.The cause of the event was the faulty ps1 pressure sensor on the exhalation sensor pcba of the eva.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.
Event or Problem Description
It was reported that while in use on a patient the 980 ventilator generated a message indicating that a extended self test (est) was required.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.

• Brand Name: 980 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: 24744959
• Report Number: 8020893-2026-00038
• Device Sequence Number: 18497420
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: (01)10884521172524(11)151024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193056
• 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): 03/31/2026

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: 980X3ENDIUU
• Device Catalogue Number: 980X3ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2015
• 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