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

Model Number	980X3ENDIJI
Medical Device Problem Codes	Device Emits Odor (1425); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that, when powered up, this pb980 ventilator had a burnt smell.The device was available for evaluation.The service personnel (sp) inspected the ventilator, identified thermal damage on the capacitor c83 and c79 on the direct current - direct current (dc-dc) converter printed circuit board assembly (pcba).Sp replaced the dc-dc converter pcba and performed all the tests and calibrations.If a failure of capacitor c83 or c79 occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.Review of the image provided confirmed that there was thermal damage to the dc-dc converter pcba.The cause of the reported event was isolated to a faulty dc-dc converter pcba.There is an existing internal corrective action related to the dc-dc converter pca.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, when powered up, this 980 ventilator had a burnt smell.The ventilator was not in use on a patient at the time of the reported event.Evaluation of the ventilator by service personnel identified thermal damage of the direct current (dc)-dc converter printed circuit board assembly (pcba).
Additional Manufacturer Narrative
Section d9 was updated due to part received.H3 device evaluation summary: was updated due to analysis of received part.Medtronic conducted an investigation based on all information received.It was reported that, when powered up, this pb980 ventilator had a burnt smell.The device was available for evaluation.The service personnel (sp) inspected the ventilator, identified thermal damage on the capacitors on the direct current - direct current (dc-dc) converter printed circuit board assembly (pcba).Sp replaced the dc-dc converter pcba, also replaced the oxygen sensor and performed all the tests and calibrations.One dc-dc converter pcba was returned to medtronic for analysis.Visual inspection and image review provided found capacitor c83 on dc-dc converter pcba was thermally damaged.If a failure of capacitor c83 on dc-dc converter pcba occurs while in use on a patient, the ventilator response would be a loss of ventilation to the patient.The cause of the reported event was isolated to a faulty capacitor c83 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: 22298238
• Report Number: 8020893-2025-00123
• Device Sequence Number: 8562387
• Product Code: CBK
• UDI-Device Identifier: 10884521172821
• UDI-Public: 10884521172821
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 02/16/2026

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: 980X3ENDIJI
• Device Catalogue Number: 980X3ENDIJI
• 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: 02/13/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2015
• 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