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

Model Number	980X1JADIJJ
Medical Device Problem Codes	Product Quality Problem (1506); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during annual preventative maintenance, when this 980 ventilator had a new breath delivery (bd) power control distribution assembly was replaced, when it was powered on, it alarmed, would not start up and could not be used.There was no patient involvement.
Additional Manufacturer Narrative
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 during annual preventative maintenance, when this 980 ventilator had a new breath delivery (bd) power control distribution assembly was replaced, when it was powered on, it alarmed, would not start up and could not be used.The device was available for evaluation.While the service personnel (sp) was performing preventative maintenance, found 980 ventilator had a new breath delivery (bd) power controller/distribution printed circuit board assembly (pcba) assembly replacement, when it was powered on, it alarmed, would not start up and could not be used.Sp replaced the bd power controller/distribution pcba assembly.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One bd power controller/distribution pcba assembly was returned to medtronic for analysis, disassembled and tested separately.The bd power distribution pcba portion of the assembly was visually inspected and functionally tested with no malfunction or product deficiency observed.Visual inspection of the bd power controller pcba portion of the assembly showed no anomalies.The bd power controller pcba was attached to the failure investigation test ventilator for analysis.The ventilator was powered up.The ventilator failed to power ¿on¿.Further analysis revealed a short circuit condition, which determined integrated circuit (u5) on the bd power controller pcba was faulty.Analysis identified a faulty u5 which could lead to loss of ventilation (lov) if the failure occurred while in use on a patient.The cause of the event was isolated to a faulty u5 on bd power controller pcba.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: 25255627
• Report Number: 8020893-2026-00055
• Device Sequence Number: 13389865
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: (01)10884521171558(11)181123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2018
• 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