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

Model Number	980U3ESDIUU
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to chile privacy regulations.Medtronic personnel reported event to manufacturer on behalf of the customer.H3.The ventilator has been received by medtronic and under evaluation.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 had a loss of ventilation.The patient was manually ventilated using an artificial manual breathing unit (ambu) bag.There was no injury to the patient.A review of the ventilator logs indicate the ventilator experienced a loss of ventilation after an attempt to enter into backup ventilation (buv).
Additional Manufacturer Narrative
Section h3 updated due to device evaluation.Section h6 evaluation codes updated due to device evaluation.Method code (annex b), additional code added.Component code (annex g), removed g07003 and added g07001.H3: device evaluation summary: it was reported that while in use on a patient, this 980 ventilator had a loss of ventilation.A review of the ventilator logs indicate the ventilator experienced a loss of ventilation after an attempt to enter into backup ventilation (buv).The service personnel (sp) inspected the ventilator, confirmed unit entered loss of ventilation (lov) through logs however after a week of testing, the reported event was not replicated and based on the logged codes, however, after consulting with technical support, sp replaced the pneumatic interface (pi) printed circuit board assembly (pcba) and the direct current (dc)-dc converter pcba as a preventive measure.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.With the available information, the cause of the reported loss of ventilation could not be established.Based upon the information in the logs, a potential cause was due to a transient communications issue between the pi pcba and the breath delivery (bd) central processing unit (cpu).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: 24259096
• Report Number: 8020893-2026-00015
• Device Sequence Number: 15853030
• Product Code: CBK
• UDI-Device Identifier: 10884521201545
• UDI-Public: (01)10884521201545(11)180705
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 980U3ESDIUU
• Device Catalogue Number: 980U3ESDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/15/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2018
• 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