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

Model Number	980X3JADIJJ
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	08/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to japanese privacy regulations.The 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 during servicing this 980 ventilator failed the circuit pressure test while performing the short self test (sst).The device was available for evaluation.While the service personnel (sp) was performing service, sp found unit had inspiratory auto zero solenoid not operational message.Sp replaced inspiratory flow module printed circuit board assembly (ifm pcba) to address the reported issue.Additionally sp found extended self test with air psol liftoff current out of range (oor) message in memory and sp replaced mix proportional solenoid (psol).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The mix psol was not returned for failure analysis.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 powered up but failed est (extended self-test) circuit pressure test.After a thorough investigation, a faulty so1 in 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 determined to be consistent with a faulty autozero solenoid (so1) in the 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during servicing this 980 ventilator failed the circuit pressure test while performing the short self test (sst).The ventilator was not in use on a patient at the time of the reported event.

• 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: 19543506
• Report Number: 8020893-2024-00179
• Device Sequence Number: 20759392
• 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): 06/14/2024

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: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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