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

Model Number	980U1ENASAA
Medical Device Problem Codes	Smoking (1585); Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while in use on a veterinary patient this 980 ventilator generated a device alert.Although patient intervention details are unknown there was no injury to the patient.The device was in use at a veterinary facility and is not approved for veterinary use.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a veterinary patient this 980 ventilator generated a device alert.The device was available for evaluation.The medtronic service engineer (se) inspected the device and found multiple background diagnostic codes in the ventilator logs and confirmed the reported issue.To resolve the issue the direct current (dc) ¿ dc converter printed circuit board assembly (pcba) was replaced.The ventilator passed all testing per manufacturer specifications at the time of service the dc-dc converter pcba was returned to medtronic for further evaluation.The dc-dc converter pcba was being functionally tested when there was smoke seen from the dc-dc converter pcba capacitor.The cause of the smoke was isolated to the c83 capacitor on the dc-dc converter pcba.The device was in use at a veterinary facility and is not approved for veterinary use.Based on smoke seen during product analysis and the potential for injury to the investigator, the event is being reported.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation summary: medtronic conducted an investigation based upon all information received.It was reported that while in use on a veterinary patient this 980 ventilator generated a device alert.The device was available for evaluation.The medtronic service engineer (se) inspected the device and found multiple background diagnostic codes in the ventilator logs and confirmed the reported issue.To resolve the issue the direct current (dc) ¿ dc converter printed circuit board assembly (pcba) was replaced.The ventilator passed all testing per manufacturer specifications at the time of service the dc-dc converter pcba was returned to medtronic for further evaluation.The dc-dc converter pcba was being functionally tested when there was smoke seen from the dc-dc converter pcba capacitor.The cause of the smoke was isolated to the c83 capacitor on the dc-dc converter pcba.The device was in use at a veterinary facility and is not approved for veterinary use.Based on smoke seen during product analysis and the potential for injury to the investigator, the event is being reported.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it has met all medtronic quality s pecifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that while in use on a veterinary patient this 980 ventilator generated a device alert.Although patient intervention details are unknown there was no injury to the patient.The device was in use at a veterinary facility and is not approved for veterinary use.

• 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: kelly adams ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 13563433
• Report Number: 8020893-2022-00037
• Device Sequence Number: 19947710
• Product Code: CBK
• UDI-Device Identifier: 10884521201385
• UDI-Public: 10884521201385
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: 980U1ENASAA
• Device Catalogue Number: 980U1ENASAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2015
• 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