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

Model Number	980X3ENDIUU-RMF
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while in use on a patient, this 980 ventilator generated a back up ventilation (buv) background fault.The patient was removed from the ventilator and placed on an alternate ventilator with no injury.The biomedical engineer then reported the ventilator failed the extended self test (est) after.
Additional Manufacturer Narrative
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 generated a back up ventilation (buv) background fault.The biomedical engineer then reported the ventilator failed the extended self test (est) after.The device was not available for evaluation.The reported issue was addressed remotely.When the customer reached out to technical support personnel for help, based on the background diagnostic code the technical support personnel advised the customer to replace pneumatic interface printed circuit board assembly (pcba) or exhalation valve assembly (eva).The biomedical engineer is awaiting the eva to arrive to repair.With the information available, the cause of the event was isolated in the field to a potential fault in eva.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
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 generated a back up ventilation (buv) background fault.The biomedical engineer then reported the ventilator failed the extended self test (est) after.The device was not available for evaluation.Thecustomer's biomedical (biomed) engineer reached out to medtronic service personnel (sp) for troubleshooting, based on the codes displayed, sp advised the biomed exchange the pneumatic interface (pi) printed circuit board assembly (pcba) from another ventilator, and run est, short self test (sst) and ventilate on test lung.The problem reoccurred and the unit alarmed with breath delivery (bd) background codes.Sp then instructed the biomed to replace the exhalation valve assembly (eva).Biomed restored the pi pcba and while replacing the eva found a secondary issue of the ev cable being damaged.Biomed installed a new eva along with the new ev cable.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the reported buv and est failure were isolated to a potential fault in the eva.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: 20150302
• Report Number: 8020893-2024-00308
• Device Sequence Number: 19886153
• Product Code: CBK
• UDI-Device Identifier: 10884521592926
• UDI-Public: 10884521592926
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: 980X3ENDIUU-RMF
• Device Catalogue Number: 980X3ENDIUU-RMF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2016
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown