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

Model Number	980U3ENDICU
Medical Device Problem Codes	Improper Flow or Infusion (2954); Pressure Problem (3012)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected section: b7, d1, d3, e2, e3, e4 correction to section g2: additional report sources added.Correction to h3: device evaluation summary: issue identified during product analysis.Medtronic conducted an investigation based on all information received.It was reported that during use on a patient the 980 ventilator triggered a peak pressure alarm with the alarm set to 40 cmh2o.The device was available for evaluation.The service personnel (sp) inspected the ventilator, ran the unit on test lung with similar patient settings and peak pressure alarm occurred quickly.Sp ran through analog data testing with gold standard tubing and found leak.Sp replaced exhalation valve assembly (eva) after which unit had no leak and no peak pressure alarms.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One eva was returned to medtronic for analysis.Visual inspection showed no anomalies.The returned eva was attached to failure investigation test ventilator for analysis.The unit powered up and at calibration it failed pressure sensor cross check.Further investigation found pressure sensor (ps1) on the exhalation sensor pcba of the eva was faulty.The ventilator¿s response to a failure of the ps1 while in use on a patient would be backup ventilation (buv) to the patient.The cause of the reported event were incorrect pressure readings obtained from ps1 on the exhalation sensor pcba of the eva resulting in peak pressure alarms, prior to failure of the part.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.
Additional Manufacturer Narrative
H3: device evaluation summary: the service personnel (sp) inspected the ventilator, ran the unit on test lung with similar patient settings and peak pressure alarm occurred quickly.Sp ran through analog data testing with gold standard tubing and found leak.Sp replaced exhalation valve assembly (eva), after which unit had no leak and no peak pressure alarms.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.One eva was returned to medtronic for analysis.Visual inspection showed no anomalies.The returned eva was attached to failure investigation test ventilator for analysis.The unit powered up and at calibration it failed pressure sensor cross check.Further investigation found pressure sensor (ps1) on the exhalation sensor pcba of the eva was faulty.The worst case ventilator response to the failure of the ps1 while in use on a patient, would be backup ventilation (buv) to the patient.The cause of the reported event was a drifting ps1 on the exhalation sensor pcba of the eva resulting in an incorrect pressure reading and peak pressure alarms.Further action was not required because the event is included in a data monitoring plan.A device history record (dhr) review is not required since there is no indication of a potential manufacturing issue.A medical safety review (msr) was performed and the results show that reported associated harm(s) and severities have been reviewed and are properly assessed within the risk document.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 during use on a patient, this 980 ventilator triggered a peak pressure alarm with the alarm set to 40 cmh2o.When the customer decreased the pressure controlled ventilation (pcv) from 20cmh2o to 8cmh2o, the ventilator was still resulting in pressures above 40 cmh2o and it sounded like there was a leak coming from near the expiratory filter.The patient was removed from the ventilator and during the transfer to an alternate ventilator, the patient desaturated with a drop in blood pressure due to additional sedation.Reportability reassessed based on failure analysis.

• 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: 25124271
• Report Number: 8020893-2026-00052
• Device Sequence Number: 21506389
• Product Code: CBK
• UDI-Device Identifier: 10884521171268
• UDI-Public: (01)10884521171268(11)180618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: 980U3ENDICU
• Device Catalogue Number: 980U3ENDICU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ETT TUBE SIZE 8. HUMIDIFICATION ON.
• Patient Sex: Unknown