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

Model Number	980X1JADIJJ
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to japanese privacy regulations.Japan medtronic personnel reported event to manufacturer on behalf of the customer.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.A review of the ventilator logs confirmed the reported error code occurred during ventilation and the system response was buv.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 running on a test lung, these 980 ventilators entered into backup ventilation (buv).The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Update to section d unique identifier (udi) #.Section d9 updated due to part return section.H6 evaluation codes were updated due to analysis of returned part method code (annex b): additional code added.Result code (annex c): remove c20 and add c13 and c02.Conclusion code (annex d): remove d15 and add d0302.Component code (annex g): remove g07003 and add g0201205.Section h3 device evaluation summary: updated due to analysis of returned part.Medtronic conducted an investigation based on all information received.It was reported that while running on a test lung, this 980 ventilator entered into backup ventilation (buv).The device was available for evaluation.A review of the ventilator logs confirmed the reported error code occurred during ventilation and the system response was buv.The service personnel (sp) inspected the ventilator, found expiratory autozero failed code in logs and based on code replaced the exhalation valve assembly (eva).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One eva was returned for further analysis.A visual inspection was carried out on the returned eva and no anomalies were observed.The exhalation sensor printed circuit board assembly (pcba) of the returned eva was prior to the implementation of a change to address autozero solenoid (so1) failures; therefore, no further testing was performed.Investigation determined if so1 were to fail while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the event was determined to be a faulty so1.The serial number of the exhalation sensor pcba of the returned eva is in scope of the existing corrective action.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21703854
• Report Number: 8020893-2025-00070
• Device Sequence Number: 17307460
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: (01)10884521171558(11)210708(21)35B2104489
• 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): 07/03/2025

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: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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