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

Model Number	980X1ENDIUU
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
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 the 980 ventilator did not pass the short self test (sst) and did not pass the mix accumulator test portion of the extended self test (est).The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue and exhalation valve calibration failed.Sp replaced the inspiratory flow module printed circuit board assembly (ifm pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One ifm pcba was returned to medtronic for analysis.A visual inspection was carried out on the returned component, and no anomalies were observed.The ifm pcba was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.While performing calibrations, the ventilator failed the ¿exhalation valve calibration¿.The calibration failure was isolated to the pressure sensor (ps1) on the ifm pcba.If a failure of 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 determined to be an issue with the ps1 on the ifm pcba.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 the 980 ventilator did not pass the short self test (sst) and did not pass the mix accumulator test portion of the extended self test (est).There was no patient involved.

• 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: 23560808
• Report Number: 8020893-2025-00261
• Device Sequence Number: 15868089
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)161220
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/14/2025

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2016
• 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