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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 840 ventilator had a faulty display.The ventilator was not in use on a patient at the time of the event.
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.
Additional Manufacturer Narrative
The field service engineer (fse) replaced the gui pcba (graphical user interface, printed circuit board) and the backlight inverters.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: a graphic user interface (gui) printed circuit board (pcb), gui backlight assembly and a gui backlight cable 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.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: 6613893
• Report Number: 8020893-2017-06414
• Device Sequence Number: 19033100
• Product Code: CBK
• UDI-Device Identifier: 10884521077065
• UDI-Public: 10884521077065
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/26/2018

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: 4-840220DIJI-EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: Not provided; 10/22/2017; 01/25/2018
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 06/06/2017; 10/27/2017; 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1