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

Model Number	980X3JADIJJ
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: the device has been received and is under evaluation.A review of the ventilator logs confirmed a loss of ventilation (lov) to the patient at the time of the event.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 in use on a patient, this 980 ventilator sounded an alarm and ¿ventilation not possible¿ was displayed.There was no injury to the patient.
Additional Manufacturer Narrative
Section d9 correction section h6 evaluation codes were updated due to evaluation of device.Method code (annex b): remove b21 and add b01 result code (annex c): remove c21 and add c13 conclusion code (annex d): remove d16 and add d02 component code (annex g): remove g07003 and add 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 sounded an alarm and ¿ventilation not possible¿ was displayed.The device was available for evaluation.A review of the ventilator logs confirmed a loss of ventilation (lov) to the patient at the time of the event.The service personnel (sp) inspected the ventilator, confirmed that unit entered lov through logs and based on the logs replaced the delivery proportional solenoid (psol) and inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the reported event was isolated to potential fault in ifm pcba and/or delivery psol.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 d9 was updated due to part return section h6 evaluation codes were updated due to analysis of returned parts.Result code (annex c), added c07 component code (annex g), removed g07001 and added g0413501 section h3 updated due to device evaluation 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 sounded an alarm and ¿ventilation not possible¿ was displayed.The device was available for evaluation.A review of the ventilator logs confirmed a loss of ventilation (lov) to the patient at the time of the event.The service personnel (sp) inspected the ventilator, confirmed that unit entered lov through logs and based on the logs replaced the delivery proportional solenoid (psol) and inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The ifm pcba was returned to medtronic for analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.The delivery psol was returned to medtronic for analysis.Visual inspection showed no anomalies.The returned delivery psol was attached to failure investigation test ventilator for analysis.The unit powered up and failed the leak test.Analysis determined returned delivery psol was faulty.If a failure of the delivery psol occurs while in use on a patient, the ventilator response would be backup ventilation or loss of ventilation.The cause of the reported lov was isolated to a faulty delivery psol.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: 24415552
• Report Number: 8020893-2026-00021
• Device Sequence Number: 10608045
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: (01)10884521172531(11)210901
• 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,Followup
• Report Date (Section B): 05/29/2026

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 05/15/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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