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

Model Number	980U3ENDICU
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	03/04/2024
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.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.The sp performed the extended self test (est) and identified the unit failed est with a diagnostic code (exhalation auto zero solenoid not operational).Based on the code, sp replaced the exhalation sensor printed circuit board assembly (pcba).The unit passed all calibrations and tests per manufacturer specifications at the time of service.One exhalation sensor pcba was returned for failure investigation.The part was visually inspected with no faults or damage observed.The exhalation sensor pcba was attached to the test ventilator and powered up.The unit powered up normally and no errors were recorded in the diagnostic logs.During est, the unit failed the circuit pressure test portion of est.After a thorough investigation, this failure was traced back to a faulty autozero solenoid (so1).Investigation determines if so1 were to fail while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the event was isolated to a faulty autozero solenoid (so1) on the exhalation sensor pcba.There is an existing previous internal investigation regarding this 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.
Event or Problem Description
It was reported that this 980 ventilator generated a ventilator inoperative message.The ventilator was not in use on a patient at the time of the reported event.

• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20197195
• Report Number: 8020893-2024-00314
• Device Sequence Number: 20552828
• Product Code: CBK
• UDI-Device Identifier: 10884521171268
• UDI-Public: 10884521171268
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 980U3ENDICU
• Device Catalogue Number: 980U3ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2020
• 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