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

Model Number	980X1JADIJJ
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Device Emits Odor (1425); No Flow (2991); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information and 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.The device is expected to be evaluated.Device logs obtained on 08-dec-2025.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.
Event or Problem Description
It was reported that while in use on a patient, this 980 ventilator had a "popping sound and a burning smell".Ventilation continued, but the screen blacked out and a red "warning lamp" turned on.There was no injury to the patient.Although it was reported that ventilation continued, a review of the logs indicate the ventilator had a loss of ventilation.
Additional Manufacturer Narrative
Section d9 was updated due to device evaluation.Section h6 evaluation codes were updated due to device evaluation: method code (annex b) remove b24 and add b01 result code (annex c) remove c21 and add c13 conclusion code (annex d) remove d16 and add d14, d02 component code (annex g) remove g07003 and add g02005 h3 device evaluation summary: medtronic conducted an investigation based on all information received.It was reported that while in use on a patient, this 980 ventilator had a "popping sound and a burning smell".Ventilation continued, but the screen blacked out and a red "warning lamp" turned on.Although it was reported that ventilation continued, a review of the logs indicate the ventilator had a loss of ventilation (lov).The device was available for evaluation.The service personnel (sp) inspected the ventilator, found unit had a burnt smell and alarmed upon power up.Sp replaced the direct current (dc) to dc converter printed circuit board assembly (pcba) which had an evidence of thermal damage.Further, sp found unit's battery warning light was red and replaced the battery.Sp was unable to duplicate the screen blank out issue.Additionally, sp found the unit failed atmospheric pressure calibration and replaced the inspiratory flow module (ifm) printed circuit board assembly (pcba).The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The cause of the burning and popping sound which resulted unit to enter lov, was isolated in the field to potential fault in dc-dc converter pcba.The cause of the issue of unit had red warning lamp on was isolated to potential fault in the battery.The cause of the secondary issue of atmospheric calibration failure was isolated to potential fault in ifm pcba.The events are 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: 23944519
• Report Number: 8020893-2026-00001
• Device Sequence Number: 16133676
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: (01)10884521171558(11)170313
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2017
• 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