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

Model Number	980X1ENDIUU
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section b3 was estimated h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that, while in use on a patient, this 980 ventilator displayed message ventilator inoperative and a background diagnostic code indicating ventilator had entered backup ventilation.After the patient had been removed from the ventilator the biomedical engineer (biomed) observed the ventilator displayed message ¿extended self test (est) never run" and found background diagnostic codes indicating inspiratory proportional (psol) stuck and pneumatic interface analog to digital converter failure.The ventilator was not made available to medtronic for evaluation.Biomed performed est and cleared the codes.It was informed that after the performance of the est, the unit was working normally.The cause of the reported entry into backup ventilation (buv) could not be established.However, based upon the codes reported by the customer, a potential cause of the reported event was due to a temporary difference between the gas source flow and that of the proportional solenoid valve (psol).The reported est never run message occurs by design after the ventilator enters buv until a successful est is performed.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, this 980 ventilator displayed message ventilator inoperative and a background diagnostic code indicating ventilator had entered backup ventilation.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.After the patient had been removed from the ventilator the biomedical engineer (biomed) observed the ventilator displayed message ¿extended self test (est) never run" and found background diagnostic codes indicating inspiratory proportional (psol) stuck and pneumatic interface analog to digital converter failure.

• 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: 24746888
• Report Number: 8020893-2026-00040
• Device Sequence Number: 9230000
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)201016
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• 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