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

Model Number	980
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 980 ventilator failed the power on self test (post), the status display was not working, and the graphical user interface (gui) timed out.Although requested, no additional information has been provided regarding the reported issue.
Additional Manufacturer Narrative
The service engineer (se) checked the ventilator and found the cable of the status display printed circuit board was dismantled.The se reconnected the cable and 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
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: 6636985
• Report Number: 8020893-2017-06546
• Device Sequence Number: 18854667
• Product Code: CBK
• UDI-Device Identifier: 10884521201910
• UDI-Public: 10884521201910
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131252
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2017

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?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/20/2017; 11/10/2017
• Initial Report FDA Received Date: 06/13/2017
• Supplement Report FDA Received Date: 10/31/2017; 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1