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

Model Number	980X1DEDRAC
Medical Device Problem Codes	No Flow (2991); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the field service engineer identified the dc-dc converter issue as a failure out of box and replaced the part.The ventilator passed all testing per manufacturer specifications and was returned to the customer.The dc-dc converter printed circuit board (pcb) was returned to medtronic for further analysis.A visual inspection of the returned part was conducted and no anomalies were observed.The pcb was then attached to the failure investigation test ventilator for analysis.The unit was powered up.The unit failed to power up normally and there was a slight smell of over heating coming from the returned pcb.Conclusion: root cause assigned c83 electronic component failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, during servicing, a 980 ventilator failed a power on self test (post) with a dc (direct current)- dc converter failure out of box.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 ; IE
• MDR Report Key: 9889875
• Report Number: 8020893-2020-00048
• Device Sequence Number: 16275198
• Product Code: CBK
• UDI-Device Identifier: 10884521171596
• UDI-Public: 10884521171596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/27/2020

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: 980X1DEDRAC
• Device Catalogue Number: 980X1DEDRAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1