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

Model Number	980X1ENDIUU
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient, this pb980 ventilator generated a high alert with a "mix air flow sensor reading out of range (oor)" message and entered mix backup ventilation (buv).The device was available for evaluation.A review of the ventilator logs confirmed the ventilator entered into buv.The service personnel (sp) inspected the ventilator and found that the unit had generated a high alert with a ¿mix air flow sensor reading out of range (oor)¿ message.The sp reseated all circuit boards, replaced a missing knob and performed preventive maintenance to replace the coin cell batteries.The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.The suspected cause of the reported event of the device entering into buv was a transient out of range mix air flow sensor measurement.The event is included in a data monitoring plan.The preventative maintenance to replace the coin batteries and a missing knob is not related to the reported 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, these 980 ventilators generated a high alert with a "mix air flow sensor reading out of range (oor)" message and entered mix backup ventilation (buv).The patient was removed from the ventilator 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: 23039866
• Report Number: 8020893-2025-00214
• Device Sequence Number: 18614416
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)170919
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/12/2025

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: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2017
• 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