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

Model Number	980X1ENDIUU
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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, while in use on a patient, this 980 ventilator generated a ventilator inoperative message.The device was available for evaluation.A review of the ventilator logs showed that the device entered into loss of ventilation (lov) at the time of the reported event.Service personnel (sp) inspected the unit and confirmed the reported issue of vent inop.Also, sp found unit having multiple direct current (dc) voltage errors.Sp replaced the dc-dc converter printed circuit board assembly (pcba) to correct the issue.The unit passed all the required calibrations and tests as per the manufacturer specifications at the time of service.The cause of the ventilator inoperative and lov issues were isolated in the field to a potential fault in the dc-dc 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.
Event or Problem Description
It was report that, while in use on a patient, this 980 ventilator generated a ventilator inoperative message.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Section d9 updated due to part return.Section h3 was updated due to analysis of returned part.Section h6 evaluation code was updated due to evaluation of device.Conclusion code (annex d), removed d02 and added d15 component code (annex g) removed g02005 and added g07001 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 generated a ventilator inoperative message.The device was available for evaluation.A review of the ventilator logs showed that the device entered into loss of ventilation (lov) at the time of the reported event.Service personnel (sp) inspected the unit and confirmed the reported issue of vent inop.Also, sp found unit having multiple direct current (dc) voltage errors.Sp replaced the dc-dc converter printed circuit board assembly (pcba) to correct the issue.The unit passed all the required calibrations and tests as per the manufacturer specifications at the time of service.One dc-dc converter pcba was returned to medtronic for analysis: the returned component was visually inspected and functionally tested with no malfunction or product deficiency observed.The cause of the event could not be established.However, the potential cause of the event was isolated to a transient issue with the 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.

• 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: 24203214
• Report Number: 8020893-2026-00008
• Device Sequence Number: 5431088
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)190304
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2019
• 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