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 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 that there was a faulty liquid crystal display.Patient involvement information was not provided by the customer.Repair will be completed at a non-medtronic location and the product is not in medtronic control.The reported complaint could not be confirmed without the product return.The complaint will be closed and reopened/updated should new information become available or if the product is returned to the manufacturer for investigation.The information has been added to the database for trending purposes and trends will continue to be monitored.A capa is not required at this time.
Additional Manufacturer Narrative
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 liquid crystal display (lcd).Patient involvement was not provided; however, it was reported that there no patient injury as a result of the event.The service engineer (se) replaced the graphic user interface (gui) printed circuit board (pcb) and backlight assembly.The se performed calibrations and extended self-testing on the device and all tests passed.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6440433
• Report Number: 8020893-2017-05435
• Device Sequence Number: 550647
• Product Code: CBK
• UDI-Device Identifier: 10884521077201
• UDI-Public: 10884521077201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/02/2017

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: 4-840220NISB-EN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1