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

Model Number	980X1JADIJJ
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a patient this 980 ventilator stopped.There were multiple out of range error codes indicating mix backup ventilation (buv) activation failure.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Section d9 estimated return date.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 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 stopped.There were multiple out of range error codes indicating mix backup ventilation (buv) activation failure.The device was available for evaluation.A review of the ventilator's logs confirmed a loss of ventilation (lov) during use on a patient.The service personnel (sp) inspected the ventilator, confirmed the reported issue from logs and based on the codes replaced the direct current (dc) - dc converter printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to potential fault in dc-dc converter pcba.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.
Additional Manufacturer Narrative
Section d4 unique identifier (udi) updated section d9 updated due to part return section h6 evaluation codes were updated due to analysis of returned part result code (annex c) additional code added component code (annex g): remove g02005 and add g0201201 h3 device evaluation summary: was updated due to analysis of returned part medtronic conducted an investigation based on all information received.It was reported that while in use on a patient this 980 ventilator stopped.There were multiple out of range error codes indicating mix backup ventilation (buv) activation failure.The device was available for evaluation.A review of the ventilator's logs confirmed a loss of ventilation (lov) during use on a patient.He service personnel (sp) inspected the ventilator, confirmed the reported out of range codes in the logs and based on the codes replaced the direct current (dc) - dc converter printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One dc-dc converter pcba was returned to medtronic for analysis.A visual inspection of the returned part was conducted, and observed that the capacitor c10 was thermally damaged.Analysis determined returned dc-dc converter pcba was faulty.If a failure of the capacitor c10 occurs while in use on a patient, the ventilator response would be a loss of ventilation.The cause of the reported event including the multiple out of range codes and the loss of ventilation was isolated to a faulty capacitor c10 on dc-dc converter pcba.The dc-dc converter pcba is in scope of a existing internal investigation.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: 22297918
• Report Number: 8020893-2025-00122
• Device Sequence Number: 12971100
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: (01)10884521171558(11)171101(21)35B1703062
• 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): 02/27/2026

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: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• 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