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

Model Number	840
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, medtronic has not received the suspect device/component from the customer for evaluation.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 keyboard issue; blocked error messages were generated.The ventilator was not in use on a patient at the time the event occurred.
Additional Manufacturer Narrative
Product analysis: a graphic user interface (gui) printed circuit board (pcb), backlight inverters pcb¿s and a keyboard were returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned components was performed, no notable conditions were found on the gui pcb and backlight inverters pcb¿s.The keyboard had contamination across arising from fluid ingress.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 u63) on the xena i pcb.No fault was found on the backlight inverters pcb¿s.The keyboard root cause was isolated to the contamination.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during preventative maintenance, the 840 ventilator did not pass the extended self-test (est), the lower display did not view properly and the keyboard did not work properly (blocked error message).

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6808558
• Report Number: 8020893-2017-07537
• Device Sequence Number: 18872665
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2017

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: 11/01/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 11/08/2017; 11/09/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 11/08/2017; 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1