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)
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 an 840 ventilator had a faulty display.Although requested, information pertaining to the use of the device at the time of the reported event and patient outcome (if applicable) has not been provided.The service engineer inspected the device and replaced the gui (graphical user interface) cpu (central processing unit) and back light inverter boards.The ventilator passed all testing and operated within the manufacturer's specifications.
Additional Manufacturer Narrative
A graphic user interface (gui) printed circuit board (pcb) was returned to covidien/medtronic¿s product analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the identified root cause of the gui pcb was isolated to a component (video graphics array controller u63) 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: 6755478
• Report Number: 8020893-2017-07221
• Device Sequence Number: 149426
• 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): 07/05/2017

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: 09/05/2017
• Initial Date Received by Manufacturer: 07/05/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 07/31/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1