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

Model Number	980U3ENDICU
Medical Device Problem Codes	Defective Alarm (1014); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 was in an inoperative status at start up and generated an error code for failing the digital to analog convertor (dac) test during the power on self test (post).Additionally, the ventilator did not pass breath delivery (bd) audio test portion of the extended self test (est).The device was available for evaluation.The service personnel (sp) inspected the ventilator, reviewed logs, confirmed the reported issue and based on est code, replaced the piezo alarm.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.One piezo alarm was returned to medtronic for analysis.Visual inspection of the returned piezo alarm found no anomalies.The piezo alarm was attached to the test ventilator and powered up.The unit failed est with a diagnostic code indicating 'alarm cable malfunction' and the piezo alarm failed to activate (no sound).It was confirmed that the piezo alarm failed to activate when initially tested.However, the act of measuring using a multimeter cleared the fault on the piezo alarm.The suspected cause of the reported post failure is a potential intermittent software issue.The cause of the reported bd audio test portion failure of est was determined to be an intermittent fault in the piezo alarm.An intermittent piezo alarm could lead to failure to alarm under a power fail condition or failure of the primary alarm.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.
Event or Problem Description
It was reported that the 980 ventilator was in an inoperative status at start up and generated an error code for failing the digital to analog convertor (dac) test during the power on self test (post). additionally, the ventilator did not pass breath delivery (bd) audio test portion of the extended self test (est).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: 22532110
• Report Number: 8020893-2025-00146
• Device Sequence Number: 12766770
• Product Code: CBK
• UDI-Device Identifier: 10884521171268
• UDI-Public: (01)10884521171268(11)210302
• 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): 07/17/2025

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: 980U3ENDICU
• Device Catalogue Number: 980U3ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• 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