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)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 980 ventilator failed the circuit pressure test with "inspiratory auto zero solenoid not operational message" during extended self test (est).The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
Issue identified during product analysis.H3: device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that the 980 ventilator failed the circuit pressure test with "inspiratory auto zero solenoid not operational message" during extended self test (est).The device was available for evaluation.The service personnel (sp) inspected the ventilator, confirmed the reported issue and replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all tests and calibrations according to the manufacturer's specifications at the time of service.One ifm pcba was returned for further analysis.Visual inspection of the returned ifm pcba found no anomalies.The ifm pcba was attached to test ventilator and powered up.The unit powered up normally and no errors were recorded in the diagnostic logs.During est, the unit failed circuit pressure test.After thorough investigation, this failure was traced back to a faulty autozero solenoid, so1.Investigation determines 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 event was isolated to faulty auto zero solenoid (so1) in ifm pcba.There is an existing previous internal investigation 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: 20197281
• Report Number: 8020893-2024-00315
• Device Sequence Number: 7650163
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2021
• 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