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

Model Number	980U3ENDICU
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use on a patient, the 980 ventilator generated a "vent inop alarm".The patient was removed from the ven tilator and placed on an alternate ventilator.
Additional Manufacturer Narrative
H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that during use on a patient, the 980 ven tilator generated a "vent inop alarm".Review of the ventilator logs indicates the device entered backup ventilation.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the ventilator was in "vent inop" as a result of entry into buv.During extended self test (est), unit failed circuit pressure test with ¿inspiratory autozero solenoid not operational" message, but after updating software to the latest revision, the ventilator passed all calibrations and tests as per manufacturer specifications with the available information, the cause of the event could not be determined.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a trending and 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
Corrections: section b5 section h6 patient code ime: remove e2401 and add e2403 imf: remove f24 and add f26.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
Correction: it was reported that during use on a patient, the 980 ventilator generated a "vent inop alarm".The patient was removed from the ventilator and placed on an alternate ventilator with no injury.A review of the ventilator logs indicates the device entered backup ventilation.

• 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: 19634464
• Report Number: 8020893-2024-00199
• Device Sequence Number: 7065509
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 06/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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