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

Model Number	980X1ENDIUU
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	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 980 ventilator did not pass the extended self test (est) with an "inspiratory autozero solenoid not operational" message.There was no patient involved.
Additional Manufacturer Narrative
H3 device evaluation summary medtronic conducted an investigation based on all information received.It was reported that the 980 ventilator did not pass the extended self test (est) with an "inspiratory autozero solenoid not operational" message.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.Sp replaced the inspiratory flow module (ifm) printed circuit board assembly (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 of the returned pcba was conducted, and no anomalies were found.The pcba was attached to the failure investigation test ventilator for analysis.An oscilloscope was also connected to measure the auto-zero solenoid response times during testing.During extended self test (est) testing, the ventilator failed the circuit pressure test, with inspiratory auto zero solenoid not operational message.The circuit pressure test was repeated a further two times and failed both times.The measured solenoid response times indicate a potential to lead to backup ventilation (buv).The fault was isolated to the auto-zero solenoid (so1).The cause of the event was isolated to a faulty so1 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.

• 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: 25562364
• Report Number: 8020893-2026-00109
• Device Sequence Number: 10318554
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)211012
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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