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

Model Number	840
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/18/2017
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 an 840 ventilator had a faulty display.There was no patient involvement at the time of the event.The service engineer inspected the device and replaced the graphical user interface (gui) printed circuit board (pcb), upgraded the backlight inverter pcbs and downloaded the recent version of the software.The ventilator passed all testing and operated within the manufacturer's specifications.
Additional Manufacturer Narrative
Backlight inverters printed circuit board (pcb) and a graphic user interface (gui) pcb were returned to covidien/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 the reported condition for the backlight inverters pcb could not be duplicated.The identified root cause of the gui pcb issue was isolated to a component (video graphics array controller u34) on the xena i pcb.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: 6719422
• Report Number: 8020893-2017-06970
• Device Sequence Number: 999546
• 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): 06/19/2017

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: 08/08/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1