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

Model Number	980X1JADIJJ
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
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.Section d9 estimated date of return h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient this 980 v entilator alarmed and went into backup ventilation (buv).The device was available for evaluation.The service personnel (sp) inspected the ventilator and based on codes sp replaced exhalation valve assembly (eva).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to potential fault in eva.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.
Event or Problem Description
It was reported that while in use on a patient this 980 ventilator alarmed and went into backup ventilation (buv).The patient was removed from the ventilator and placed on an alternate ventilator with no injury.
Additional Manufacturer Narrative
Section d9 was updated due to parts returned correction section e4 section h6 evaluation codes updated due to analysis of returned parts: result code (annex c) additional code added conclusion code (annex d) - remove d02 and add d0302 component code (annex g) - remove g07001 and add g0201205 h3 device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a patient this 980 ventilator alarmed and went into backup ventilation (buv).The service personnel (sp) inspected the ventilator and based on code replaced exhalation valve assembly (eva) along with exhalation module to breath delivery unit (bdu) backplane interconnect cable.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The eva and the exhalation module to bdu backplane interconnect cable were returned to medtronic for analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.The exhalation sensor printed circuit board assembly (pcba) of the returned eva was prior to the implementation of a change to address autozero solenoid (so1) failures.Investigation determined if so1 were to fail intermittently while in use on a patient, the ventilator response would be to enter buv.The cause of the event was isolated to an intermittent fault in the autozero solenoid (so1).The serial number of the exhalation sensor pcba of the returned eva is in scope of the existing internal corrective action.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: 20525836
• Report Number: 8020893-2024-00362
• Device Sequence Number: 9105118
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: 10884521171558
• 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
• Report Date (Section B): 05/06/2025

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: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2017
• 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