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

Model Number	980
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer (se) inspected the device and found the dc (direct current)-dc converter printed circuit board (pcb) and the graphic user interface (gui) central processing unit (cpu) pcb burned.The se replaced the dc-dc converter pcb and the gui cpu pcb.Both the gui cpu pcb and the dc-dc converter pcb were returned to medtronic for failure investigation.A visual inspection of the dc-dc converter pcba determined thermal damage to multiple components surrounding the c83 capacitor and additional thermal damage was noted on the backside of the gui pcb.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, upon turning on, a 980 ventilator had a burn smell and the unit did not switch on.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
• MDR Report Key: 8601874
• Report Number: 8020893-2019-00104
• Device Sequence Number: 2281156
• Product Code: CBK
• UDI-Device Identifier: 10884521172722
• UDI-Public: 10884521172722
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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: 980
• Device Catalogue Number: 980X3ENNISB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1