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

Model Number	840
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) replaced the gui pcb (graphical user interface, printed circuit board), the gui backlight assembly, the gui touch frame and the cable.Covidien/medtronic has not received the device/component from the customer for evaluation.
Event or Problem Description
It was reported that prior to use, the 840 ventilator had a burning smell when turned on.There was a penetration of liquid onto the screen.The ventilator was not in use on a patient at the time of the reported event.
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 found in the diagnostic logs and functionality testing was performed.An investigation was performed and the product analysis technician reported that no fault was found.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.
Additional Manufacturer Narrative
Product analysis: a touch frame printed circuit board (pcb) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed and areas of contamination were found in the pcb.The returned component was installed into a test ventilator for analysis and functionality testing was performed, no errors were found in the diagnostic logs.During extended self-test the ventilator generated an error message.An investigation was performed and the product analysis technician reported that root cause was isolated to the contamination.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6959370
• Report Number: 8020893-2017-07752
• Device Sequence Number: 891349
• Product Code: CBK
• UDI-Device Identifier: 10884521076983
• UDI-Public: 10884521076983
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 01/17/2018

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: 4-840220AIQC-FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 01/09/2018; 01/17/2018
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 01/09/2018; 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1