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	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while in use on a patient, this 980 ventilator generated a ¿backup ventilation¿ alarm.There was no injury to the patient.
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: 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 ¿backup ventilation¿ alarm.The device was available for evaluation.The service personnel (sp) inspected the ventilator and replaced the exhalation valve.The device passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to a potential fault in the exhalation valve.The manufacturing records for each device are tho roughly reviewed prior to release to ensure that it has met all medtronic quality specifications.The event is included in a trending and monitoring plan.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Section h6 evaluation codes: component code - remove g07001 and add g04135 h3: device evaluation summary: updated medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, this 980 ventilator generated a ¿backup ventilation¿ alarm.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed the reported issue.The sp found the unit switched to buv with code "expiratory pressure autozero offset failed" from memory and replaced the exhalation valve assembly (eva).The device passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the event was isolated to a potential fault in the eva.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality specifications.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Evaluation codes were updated due to returned part analysis method code (annex b) additional code added result code (annex d) additional code added component code (annex g) remove g04135 and add g0301204 h3: device evaluation summary: updated due to returned part analysis medtronic conducted an investigation based upon all information received.It was reported that, while in use on a patient, this 980 ventilator generated a ¿backup ventilation¿ alarm.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue in memory, and replaced the exhalation valve assembly (eva).The ventilator passed all calibrations and tests per the manufacturer's specifications at the time of service.One eva was returned for failure investigation.A visual inspection of the returned part was conducted and no anomalies were observed.The part was attached to the test ventilator and powered up but failed auto zero calibration at the exhalation test.Upon further investigation, the pressure sensor (ps1) component on the exhalation sensor printed circuit board assembly (pcba) of the eva was found to be faulty.If a ps1 failure were to occur while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the reported event of buv was isolated to a faulty ps1 on the exhalation sensor pcba of the 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.

• 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: 18808095
• Report Number: 8020893-2024-00091
• Device Sequence Number: 15277599
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: 10884521172531
• 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): 11/19/2024

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 03/14/2024; 11/18/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/21/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2018
• 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