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

Model Number	980U3ESDIUC
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e initial reporter cannot be provided due to privacy regulations.Medtronic personnel reported event to manufacturer on beha lf of the customer.H3: medtronic has not received the suspect device/component from the customer for evaluation nor has the device been evaluated by the medtronic service engineer.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 smoke coming from the screen and, generated a shutdown alarm.The staff unplugged the equipment, and the patient's oxygen saturation decreased to 80%, so 1 ampoule of lorazepam was administered.The patient was removed from the ventilator.
Additional Manufacturer Narrative
H3 it was reported that while in use on a patient this pb980 ventilator had smoke coming from the screen and generated a shutdown alarm.The staff unplug the equipment, the patient's oxygen saturation decrease to 80%, so 1 ampoule of lorazepam was administered.The ventilator was not made available to medtronic for evaluation.Good faith efforts were made to obtain additional details such as repair details to which there was no further information available from the customer.The investigation determined that there was insufficient information to determine the cause of the event.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20591916
• Report Number: 8020893-2024-00369
• Device Sequence Number: 8787256
• Product Code: CBK
• UDI-Device Identifier: 10884521201538
• UDI-Public: 10884521201538
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 01/03/2025

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: 980U3ESDIUC
• Device Catalogue Number: 980U3ESDIUC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2020
• 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