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

Model Number	980U1ENASAA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when switched on this 980 ventilator was noted to have a "burning smell", a loud rattling noise, and on rebooting displayed a "ventilator inoperative" message.There was no reported patient involvement.
Additional Manufacturer Narrative
Section e.Australia medtronic personnel reported event to manufacturer on behalf of the customer.H3 h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that when switched on, this pb980 ventilator was noted to have a "burning smell", a loud rattling noise, and on rebooting displayed a "ventilator inoperative" message.A review of the ventilator logs indicated there was evidence of a loss of ventilation (lov) during use.The service personnel (sp) inspected the ventilator and observed that the unit displayed a "ventilator inoperative message" and generated a clicking noise when turned on.Sp replaced the direct current-direct current (dc-dc) converter printed circuit board assembly (pcba).Additionally, sp installed a new exhalation valve flow sensor (evq), as the customer had removed the existing evq prior to sp's visit.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.Review of the dc-dc converter pcba image provided, the dc-dc converter pcba showed discoloration on capacitor c83, accompanied by evidence of a thermal event, confirming a faulty component.If a failure of the c83 on the 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 the dc-dc converter pcba.There is an existing internal investigation regarding the issue.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 b5 and section e updated with additional information h3 device evaluation summary: was updated based on additional information of the event.Medtronic conducted an investigation based on all information received.It was reported that while in use on a patient, this pb980 ventilator generated a "loud red alarm", a "loud rattling noise", "ventilator failure.Backup ventilation in progress" message displayed, "burning smell" and ventilation had ceased.A review of the ventilator logs indicated there was evidence of a loss of ventilation (lov) during use.The service personnel (sp) inspected the ventilator and observed that the unit displayed a "ventilator inoperative message" and generated a clicking noise when turned on.Sp replaced the direct current-direct current (dc-dc) converter printed circuit board assembly (pcba).Additionally, sp installed a new exhalation valve flow sensor (evq), as the customer had removed the existing evq prior to sp's visit.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.Review of the dc-dc converter pcba image provided, the dc-dc converter pcba showed discoloration on capacitor c83, accompanied by evidence of a thermal event, confirming a faulty component.If a failure of the c83 on the 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 the dc-dc converter pcba.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
Updated information: it was reported that while in use on a patient, this 980 ventilator generated a "loud red alarm", a "loud rattling noise", "ventilator failure.Backup ventilation in progress" message displayed, "burning smell" and ventilation had ceased.The patient was removed from the ventilator, manually ventilated, and placed on an alternate ventilator with no injury.

• 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: 22535973
• Report Number: 8020893-2025-00151
• Device Sequence Number: 12618734
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: (01)10884521201385(11)140516
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/26/2025

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: 980U1ENASAA
• Device Catalogue Number: 980U1ENASAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2014
• 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