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

Model Number	980X3JADIJJ
Medical Device Problem Codes	Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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.Issue identified during product analysis.H3: device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that while in use on a patient the there was an issue with the atmospheric pressure and the tidal volume and minute volume displayed on this 980 ventilator was greater than what was set.The device was available for evaluation.The service personnel (sp) inspected the ventilator and confirmed an issue with the atmospheric pressure and replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The atmospheric pressure is used to correct the displayed tidal volumes on the ventilator; therefore, a faulty atmospheric pressure sensor could result in the reported symptoms.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One ifm pcba was returned for failure investigation.A visual inspection was carried out on the returned ifm pcba, no anomalies were observed.The part was attached to the test ventilator and passed all calibrations, including the atmospheric pressure, but failed the circuit pressure test in extended self-test for ¿inspiratory autozero solenoid not operational¿.Further investigation traced this failure to a faulty solenoid, so1.If so1 were to fail while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the reported event was isolated in the field to a potential faulty ifm pcba related to the atmospheric pressure sensor but the reported issue was not replicated.During failure investigation, a different fault (so1) was identified on the ifm pcba.The event is included in trending and monitoring and an existing corrective action is applicable to the so1 failure.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 the there was an issue with the atmospheric pressure and the tidal volume and minute volume displayed on this 980 ventilator was greater than what was set.There was no injury to the patient.

• 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: 20423135
• Report Number: 8020893-2024-00350
• Device Sequence Number: 20937472
• 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
• Report Date (Section B): 10/10/2024

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: 09/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2018
• 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