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

Model Number	980
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the service engineer (se) inspected the device and determined the ventilator needed a new dc (direct current) to dc converter printed circuit board.Medtronic has received the component from the customer and failure analysis is underway.A supplemental medwatch report with the findings will be submitted once the investigation is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that at power up, the 980 ventilator had smoke coming from the center of the device.The ventilator was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
Device evaluation summary: a direct current (dc) - dc converter printed circuit board (pcb) and a graphical user interface (gui) pcb were returned to medtronic for failure investigation.A visual inspection of the returned dc-dc converter pcb was conducted and the following was observed: the capacitor c83 was severely thermally damaged, with smoke damage on the pcb and adjacent connector and components.Preliminary testing of the pcb, using the multimeter, revealed the following: there was a resistance reading of 1 ohm (short circuit) across the damaged capacitor c83.The part was not connected to a test ventilator to avoid further circuit damage, as the short circuit was still present inside the capacitor.A visual inspection of the returned gui pcb was conducted and the following was observed: there was significant smoke damage on the solder side of the pcb near the p1 connector.This damage was caused by a fault on the adjacent pb980 dc to dc converter pcb.The part was attached to the failure investigation test ventilator for analysis.The unit was powered up normally and no errors were recorded in the diagnostic logs.Testing was performed successfully without any errors.The unit was put into normal ventilation mode and ran successfully for 24 hours.A review of the test ventilator logs revealed that no errors and no unexpected alarms were observed during the test run in period.Despite the smoke damage this pcb was functioning correctly.There was no functional fault found.The pcb was smoke damaged.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 980 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; michael collins road mervue; galway
• MDR Report Key: 8511880
• Report Number: 8020893-2019-00082
• Device Sequence Number: 16472634
• Product Code: CBK
• UDI-Device Identifier: 10884521201507
• UDI-Public: 10884521201507
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K162738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: 980U3ENASAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/17/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1