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

Model Number	980A1ENNISB
Medical Device Problem Codes	Improper Flow or Infusion (2954); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this 980 ventilator generated an extended self test (est) failure diagnostic code with an "inspiratory auto zero solenoid not operational" message.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Section e - distributor reported on behalf of the customer in section (b)(6), service manager (b)(6) issue identified during product analysis.H3: device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that these 980 ventilators generated an extended self test (est) failure diagnostic code with an "inspiratory auto zero solenoid not operational" message.The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue and based on the code replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests as per the manufacturer's specifications at the time of service.One ifm pcba was returned for failure investigation.The part was visually inspected and no anomalies were observed.The part was attached to the test ventilator and powered up but failed the est circuit pressure test ¿inspiratory autozero solenoid not operational¿.After a thorough investigation, a faulty autozero solenoid (so1) on the ifm pcba was identified.If an so1 failure were to occur while in use on a patient, the ventilator response would be to enter backup ventilation (buv).The cause of the event was identified as a faulty autozero solenoid (so1) on the ifm pcba.There is an existing previous internal i nvestigation regarding this issue.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: 20322981
• Report Number: 8020893-2024-00340
• Device Sequence Number: 11949217
• Product Code: CBK
• UDI-Device Identifier: 10884521201897
• UDI-Public: 10884521201897
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: 980A1ENNISB
• Device Catalogue Number: 980A1ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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