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

Model Number	980X1ENDIUU
Medical Device Problem Codes	Improper Flow or Infusion (2954); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Issue identified during product analysis.H3: device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that the 980 ventilator did not pass the short self test (st) with the exhalation solenoid was not operational.The device was available for evaluation.The service personnel (sp) inspected the ventilator, found the unit failed the short self test (sst) flow sensor cross check test with the exhalation solenoid not operational message, and replaced the exhalation valve assembly (eva) and exhalation module cable.As an additional finding, the sp identified that the exhalation valve failed to calibrate and replaced the exhalation valve flow sensor (evq) due to a bent thermistor.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The exhalation module cable was returned to medtronic for analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.One eva was returned to medtronic for analysis.A visual inspection of the returned eva found no anomalies.As the reported issue was the subject of a previous investigation and the exhalation sensor printed circuit board assembly (pcba) of the returned eva was prior to the implementation of a change to address autozero solenoid (so1) failures, no further testing was performed.Investigation determines if so1 were to fail while in use on a patient, the ventilator response would be to enter backup ventilation (buv).One evq was returned to medtronic for analysis.Visual inspection showed the thermistor within the flow sensor chamber was damaged.The evq was attached to the failure investigation test ventilator for analysis.The ventilator was powered up and failed flow sensor calibration, confirming the evq was faulty the cause of the reported event was determined to be a faulty autozero solenoid (so1) on the exhalation sensor pcba of the eva.The serial number of the exhalation sensor pcba of the eva is in scope of the existing internal corrective action.The cause of the additional flow sensor calibration issue was isolated to a bent thermistor in evq.This additional 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 reported that the 980 ventilator did not pass the short self test (sst) with the exhalation solenoid was not operational.There was no patient involved.

• 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: 22919366
• Report Number: 8020893-2025-00201
• Device Sequence Number: 9865371
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)210121
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/28/2025

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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