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

Model Number	980X3ENDIUU-RMF
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	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this 980 ventilator generated a power on self test (post) diagnostic code.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Issue identified during product analysis.H3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that this 980 ventilator generated a power on self test (post) diagnostic code.The device was available for evaluation.Service personnel (sp) inspected the unit and confirmed the reported issue.After reseating the exhalation valve cable from the backplane and then the inspiratory flow module (ifm) and all harness cables in the ifm, post consistently passed.While sp was testing the ventilator on a test lung, a "background diagnostic code" was generated and sp also noted the "bd alarm not working" when alternating current (ac) power and batteries were removed.Sp replaced the pneumatic interface (pi) printed circuit board assembly (pcba) for the background diagnostic code and bd power controller pcba for the alarm issue.The unit passed all the required calibrations and tests as per manufacturer specifications at the time of service.One bd power controller pcba was returned for analysis.The returned component was visually inspected and functionally tested with no malfunction or product deficiency observed.One pi pcba was returned for analysis.A visual inspection of the returned part was conducted and no anomalies were observed.The pi pcba was attached to the failure investigation test ventilator for analysis.During calibration, the unit failed, saying "unable to build pressure in pressure sensor".The r8 resistor was open-circuited on one pin.The pi pcba was found to be faulty.If a failure of r8 resistor occurs while in use on a patient, the ventilator response would be to enter into backup ventilation (buv).The investigation found adjustment with the connections addressed the post issue but could not determine the cause.However, the cause for the "background diagnostic code" was isolated to a faulty r8 resistor on the pi pcba.Although the bd power controller pcba was replaced in the field for the "bd alarm not working" problem, the returned component was tested satisfactorily.With the information available, a likely cause could not be determined.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.

• 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: 21763341
• Report Number: 8020893-2025-00079
• Device Sequence Number: 8455864
• Product Code: CBK
• UDI-Device Identifier: 10884521592926
• UDI-Public: 10884521592926
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/03/2025

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: 980X3ENDIUU-RMF
• Device Catalogue Number: 980X3ENDIUU-RMF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2014
• 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