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

Model Number	980X3ENDIUU
Medical Device Problem Codes	Mechanical Problem (1384); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during annual preventative maintenance performed by medtronic, this 980 ventilator was found to have damage to the direct current (dc) - dc printed circuit board assembly (pcba). the ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Issue identified during product analysis.H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during annual preventative maintenance performed by medtronic, this 980 ventilator was found to have damage to the direct current (dc) - dc printed circuit board assembly (pcba).Service personnel (sp) found a damaged dc-dc converter pcba and replaced it.Additionally, sp found background user interface (ui) communication codes in logs and based on codes, replaced graphical user interface (gui) central processing unit (cpu) pcba and ui pcba.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The dc-dc converter pcba was returned to medtronic for further analysis.A visual inspection of the returned part was conducted and it was observed that component c83 had thermal damage.If a failure of the c83 capacitor occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The gui pcba and the ui pcba were returned to medtronic for further analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.The cause of the reported event was isolated to a faulty capacitor c83 on dc-dc converter pcba.The dc-dc converter pcba serial number is in scope of a existing internal investigation.The cause of the additional ui communication error issue could not be established.However, a potential cause was an issue with communications between ui pcba and gui cpu pcba addressed during the repair.This additional issue 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: 25178428
• Report Number: 8020893-2026-00054
• Device Sequence Number: 18814782
• Product Code: CBK
• UDI-Device Identifier: 10884521172524
• UDI-Public: (01)10884521172524(11)181210
• 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): 05/14/2026

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: 04/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• 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