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

Model Number	980X3JADIJJ
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon turning on, this 980 ventilator¿s exhalation valve made abnormal movements then smoke was emitted afterwards.The ventilator was not in use on a patient at the time of the reported event.
Additional Manufacturer Narrative
This device was in japan medtronic control.H3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that upon turning on, this 980 ventilator¿s exhalation valve made abnormal movements then smoke was emitted afterwards.The device was available for evaluation.Japan service evaluated the unit and found thermal damage to c83 capacitor on the direct current (dc) to dc converter printed circuit board assembly.The cause of the reported event was isolated to the c83 capacitor on the dc-dc pcba.There is an existing previous internal investigation regarding this issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Section b5 updated section d9 updated due to the part return and analysis h3: device evaluation summary: updated due to the part return and analysis medtronic conducted an investigation based upon all information received.It was reported that during service by medtronic service personal (sp) when turning on this 980 ventilator¿s exhalation valve made abnormal movements then smoke was emitted afterwards.The device was available for evaluation.During servicing medtronic service personnel (sp) observed smoke emitted was coming from the dc-dc pcba and replaced it.The ventilator passed all test and calibrations per manufacturer specifications at the time of service.One dc-dc pcba was received for failure analysis.A visual inspection of the returned part was conducted, and it was observed that capacitor c83 had thermal damage.If a failure of the capacitor c83 occurs, the ventilator response would be a loss of ventilation.The cause of the event was isolated to faulty c83 on dc-dc pcba.There is an existing previous internal investigation regarding this issue.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
Updated: it was reported that during service by medtronic service personal (sp) when turning on this 980 ventilator¿s exhalation valve made abnormal movements then smoke was emitted afterwards.The ventilator was not in use on a patient at the time of the reported event.

• 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: 18682078
• Report Number: 8020893-2024-00072
• Device Sequence Number: 15001237
• Product Code: CBK
• UDI-Device Identifier: 10884521172531
• UDI-Public: 10884521172531
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: 980X3JADIJJ
• Device Catalogue Number: 980X3JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2015
• 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