MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	840
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, when an 840 ventilator was turned the device failed the post (power on self-test).The ventilator was not in use on a patient at the time the event occurred.The service engineer (se) inspected the device and replaced the graphic user interface (gui) central processing unit (cpu) printed circuit board (pcb) and backlight inverter pcbs.The se performed extended self-testing on the device and all tests passed.
Additional Manufacturer Narrative
A backlight inverter printed circuit board (pcb), graphic user interface (gui) backlight cable and a gui pcb were returned to covidi en/medtronic¿s product analysis.A visual inspection found no notable conditions.No errors were recorded in the diagnostic logs.An investigation was performed and the product analysis technician reported that no fault was found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6752586
• Report Number: 8020893-2017-07177
• Device Sequence Number: 16547974
• Product Code: CBK
• UDI-Device Identifier: 10884521077058
• UDI-Public: 10884521077058
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K970460
• 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): 06/30/2017

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: 840
• Device Catalogue Number: 4-840220DIEC-SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1