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

Model Number	980X3JADIJJ
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information and section e initial reporter cannot be provided due to japanese privacy regulations.Section e.Japan.Medtronic personnel reported event to manufacturer on behalf of the customer.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.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 this 980 ventilator alarmed and switched to back up ventilation (buv).The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Update to section d unique identifier (udi) # section d9 updated due to part return section h6 evaluation codes were updated due to analysis of returned parts result code (annex c) additional codes added h3 device evaluation summary: was updated due to analysis of returned parts medtronic conducted an investigation based upon all information received.It was reported that while in use this 980 ventilator alarmed and switched to back up ventilation (buv).The device was available for evaluation.A review of the ventilator logs confirmed the reported buv.The service personnel (sp) inspected the ventilator, confirmed the reported issue and based on the diagnostic code generated in the logs, sp replaced the delivery proportional solenoid (psol) and inspiratory flow module (ifm) printed circuit board assembly (pcba).After part replacement, the unit generated air and oxygen supply pressure drop alarm and the gas supply sensor pcba and the gas supply sensor cable were replaced.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.One ifm pcba and gas supply sensor cable were returned to medtronic for analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.One gas supply sensor pcba was returned to medtronic for analysis.A visual inspection of the returned pcba was conducted and no anomalies were observed.The gas supply sensor pcba was attached to the test ventilator and powered up.As soon as the air and o2 supply were switched on, an audible gas leak was heard.Upon further inspection, pressure sensors, ps1 and ps2 on the gas supply sensor pcba were found faulty.If both ps1 and ps2 on the gas supply sensor pcba fail simultaneously while the ventilator is in use on a patient, it would result in a loss of ventilation to the patient.One delivery psol was returned to medtronic for analysis.A visual inspection of the returned psol was conducted and no anomalies were observed.The psol was attached to the test ventilator and powered up.During extended self test (est), the unit failed the leak test with 'delivery psol leak exceeds failure limit' message, confirming the delivery psol was faulty.If a failure of the delivery psol occurs while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the reported event was isolated to a faulty delivery psol.The cause of the secondary issue of air and oxygen supply pressure drop alarm was isolated to faulty ps1 and ps2 on the gas supply sensor pcba.The events are included in the 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
Section d9 updated due to device evaluation section h6 evaluation codes updated due to device evaluation: method code (annex b) remove b17 and add b01 result code (annex c) remove c20 and add c13 conclusion code (annex d) remove d15 and add d02 component code (annex g) remove g07003 and add g07001 h3 device.Evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use this 980 ventilator alarmed and switched to back up ventilation (buv).The device was available for evaluation.A review of the ventilator logs confirmed the reported buv.The service personnel (sp) inspected the ventilator, confirmed the reported issue and based on the diagnostic code generated in the ventilator logs, sp replaced the delivery proportional solenoid (psol) and inspiratory flow module (ifm) printed circuit board assembly (pcba).After part replacement, the unit generated an air and oxygen supply pressure drop alarm and the gas supply sensor pcba and the gas supply sensor cable were replaced.The unit passed all calibrations and tests per the manufacturer's specifications at the time of service.The cause of the reported event was isolated to a potential fault in the delivery psol and/or ifm pcba.The cause of the secondary issue was isolated to a potential fault in the gas supply sensor pcba and/or gas supply sensor cable.The events are included in the 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.

• 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: 21020687
• Report Number: 8020893-2024-00429
• Device Sequence Number: 14445280
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: (01)10884521172531(11)141022(21)35B1401646
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2025

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 05/01/2025; 07/03/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 05/02/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2014
• 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