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

Model Number	980X3JADIJJ
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during use on a patient, the 980 ventilator entered into backup ventilation (buv).The patient was transferred to an alternate ventilator with no injury.
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e.Japan medtronic personnel reported event to manufacturer on behalf of the customer.H3.The device has been received and is under evaluation.A review of the ventilator logs confirm the reported event.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.
Additional Manufacturer Narrative
Section h6 evaluation codes were updated due to device evaluation and and analysis of returned parts method code (annex b) remove b21 and add b01 result code (annex c) remove c21 and add c13 and c07 conclusion code (annex d) remove d16 and add d02 component code (annex g) remove g07003 and add g07001 h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported during use on a patient, the 980 ventilator entered into backup ventilation (buv).The device was available for evaluation.A review of the logs confirmed that the ventilator entered mix buv.The service personnel (sp) inspected the ventilator and found a mix subsystem failure code during power on self test (post) and replaced the mix controller printed circuit board assembly (pcba).Subsequent testing failures resulted in the sp replacing the inspiratory flow module assembly.The ventilator passed all calibrations and tests per manufacturers specification at the time of service.One mix controller pcba was returned to medtronic for analysis.Visual inspection showed no anomalies.The mix controller pcba was attached to failure investigation test ventilator for analysis.The ventilator was powered up, failed extended self test (est) with zero offset/ unable to build accumulator pressure message confirming the pcba to be faulty.Upon further analysis found components u35 and rn9 on mix controller pcba were faulty.One inspiratory flow module assembly was returned to medtronic for analysis.Visual inspection showed no anomalies.The inspiratory flow module assembly was attached to the failure investigation test ventilator for analysis.The ventilator was powered up and upon start up an audible leak could be heard coming, determining inspiratory flow module assembly faulty.The cause of the reported event which the unit entered buv was isolated to a faulty mix controller pcba and inspiratory flow module assembly.The event is included in 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: 23044559
• Report Number: 8020893-2025-00216
• Device Sequence Number: 18559081
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: (01)10884521172531(11)210216
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2021
• 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