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

Model Number	980X3ENDIUU
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this 980 ventilator did not pass the exhalation valve (ev) performance test portion of the short self test (sst) with a message indicating the pressure was out of range (oor).There was no patient involved.
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 this 980 ventilator did not pass the exhalation valve (ev) performance test portion of the short self test (sst) with a message indicating the pressure was out of range (oor).The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.The sp's troubleshooting included using a different exhalation valve flow sensor (evq) which was not successful and replacing the exhalation valve assembly (eva) and the exhalation module cable which was successful.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.The exhalation module cable was returned to medtronic for analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.One eva was returned to medtronic for analysis.Visual inspection showed no anomalies.The returned eva was attached to the failure investigation test ventilator for analysis.The unit powered up, and calibration failed with "pressure sensor cross check failed.Further analysis found that the exhalation sensor printed circuit board assembly (pcba) in the eva was faulty due to multiple component failures.One of the faulty components was the pressure sensor (ps1) which would result in the ventilator entering backup ventilation, if the fault occurs while in use on a patient.The cause of the reported event and the isolated to a faulty exhalation sensor printed circuit board assembly (pcba) in 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.

• 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: 24627348
• Report Number: 8020893-2026-00027
• Device Sequence Number: 13028705
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: (01)10884521172524(11)151216
• 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): 03/18/2026

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: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2015
• 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