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

Model Number	840
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an 840 ventilator had a gui (graphical user interface) had a lower display issue.The ventilator was not on a patient at the time of the event.The service engineer replaced the gui board and backlight inverters to correct the issue.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
Product analysis: a graphic user interface (gui) printed circuit board (pcb) and backlight inverters pcb were returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned components was performed, no notable conditions were found.The returned components were installed into a test ventilator for analysis; no errors were recorded in the diagnostic logs.An investigation was performed and the identified root cause of the gui pcb was isolated to a component (video graphics array controller u34) on the xena i pcb.No fault was found on the backlight inverters pcb.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6771309
• Report Number: 8020893-2017-07308
• Device Sequence Number: 652887
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/08/2017

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: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1