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

Model Number	980X1JADIJJ
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
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.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that, during use, this 980 ventilator¿s ¿screen blacked out, the power went off after the beep alarm sounded and then started up and operated.¿ there was no injury to the patient.
Additional Manufacturer Narrative
Section d9 was updated due to parts returned section h6 evaluation codes were updated due to analysis of parts returned method code (annex b) remove b17 and add b01 and b24 result code (annex c) remove c20 and add c13 component code (annex g) remove g07003 and add g07001 h3: device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that, during use, these 980 ventilators¿ ¿screen blacked out, the power went off after the beep alarm sounded and then started up and operated.¿ the device was available for evaluation.A review of the ventilator logs showed that the device entered into loss of ventilation (lov) at the time of the reported event.The service personnel (sp) inspected the ventilator, found evidence the unit had a power failure and the system restarted in the logs and therefore replaced breath delivery (bd) power controller printed circuit board assembly (pcba) and bd power distribution pcba.The ventilator passed all calibrations and tests per manufacturer specifications at the time of service.The bd power distribution pcba was returned to medtronic for further analysis.The component was visually inspected and functionally tested with no malfunction or product deficiency observed.One bd power controller pcba was returned to medtronic for further analysis.Visual inspection showed no anomalies.The bd power controller pcba was attached to the failure investigation test ventilator for analysis.The ventilator was powered up and found secondary alarm did not sound at the start of the power on process and bd audio test during est failed.Analysis determined that the supercap capacitor (c4) on the bd power controller pcba was faulty.If the capacitor c4 were to fail this could lead to a failure to alarm.The cause of the event could not be established.The secondary finding of bd audio test failure was isolated to a faulty capacitor (c4) on bd power controller pcba.The events are included in a trending and 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20447061
• Report Number: 8020893-2024-00354
• Device Sequence Number: 9232015
• Product Code: CBK
• UDI-Device Identifier: 10884521171558
• UDI-Public: 10884521171558
• 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): 01/16/2025

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: 980X1JADIJJ
• Device Catalogue Number: 980X1JADIJJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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