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

Model Number	980X1ENDIUU
Medical Device Problem Codes	Defective Alarm (1014); Problem with Software Installation (3013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during servicing, the 980 ventilator failed the software download.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 during servicing, this 980 ventilator failed the software download.The device was available for evaluation.While the service personnel (sp) was servicing the 980 ventilator found, the unit failed the software download.Sp replaced the breath delivery (bd) power controller pcba, bd power distribution printed circuit board assembly (pcba), main backplane pcba and main backplane to power controller cable.Also, sp found red light lit in the batteries and replaced them.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.Batteries were not returned for analysis.The bd power distribution pcba and the main backplane to power controller cable were returned to medtronic for analysis.The components were visually inspected and functionally tested with no malfunction or product deficiency observed.One main backplane pcba was returned to medtronic for analysis.Visual inspection showed no anomalies.The main backplane pcba was attached to the failure investigation test ventilator for analysis.The ventilator was powered up, but failed software download and firmware update failed to upload.One bd power controller pcba was returned to medtronic for analysis.Visual inspection showed no anomalies.The bd power controller pcba was attached to the failure investigation test ventilator for analysis.The ventilator was powered up and the unit passed the extended self test (est) and short self test (sst).Functional testing of the pcba determined that the supercap capacitor (c4) on the bd power controller pcba was faulty.If the c4 were to fail, this could lead to a failure to alarm.The cause of the software download failure issue was isolated to the faulty main backplane pcba.The cause of the secondary alarm failure issue was isolated to a faulty c4 on the bd power controller pcba.Also, the cause of the additional battery red light issue was isolated to the potential fault in the batteries.The event is included in a data 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22795831
• Report Number: 8020893-2025-00188
• Device Sequence Number: 15655620
• Product Code: CBK
• UDI-Device Identifier: 10884521171541
• UDI-Public: (01)10884521171541(11)210104
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: 980X1ENDIUU
• Device Catalogue Number: 980X1ENDIUU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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