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

Model Number	980
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service engineer (se) inspected the device and verified the reported issue.The se replaced the graphical user interface (gui) and the breath delivery (bd) central processing unit (cpu).The se updated the software to the current revision and upgraded the battery firmware.The se performed calibrations and extended self-testing on the device and all tests passed.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 patient, a 980 ventilator alarmed with error codes, was inoperable and began backup ventilation.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.
Additional Manufacturer Narrative
Device evaluation: the graphical user interface (gui) printed circuit board (pcb) and the breath delivery (bd) pcb were returned for failure investigation.The components were visually inspected and functionally tested.The reported failure could not be replicated.There was no fault found.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; micheal collins rd mervue; galway
• MDR Report Key: 7230814
• Report Number: 8020893-2018-00053
• Device Sequence Number: 13725758
• Product Code: CBK
• UDI-Device Identifier: 10884521171633
• UDI-Public: 10884521171633
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 03/13/2018

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: 980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1