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)
Date of Event	04/28/2017
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 an 840 ventilator had a faulty display.The ventilator was not on a patient at the time of the event.The service engineer replaced the gui (graphical user interface) board and loaded the software to correct the issue.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
Correction: remove (b)(4) 2017, remove date (b)(4) 2017.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 an unspecified display issue.The service engineer replaced the graphical user interface (gui) board and loaded the software to address the issue.

• Brand Name: 840 VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• MDR Report Key: 6635732
• Report Number: 8020893-2017-06535
• Device Sequence Number: 14428
• Product Code: CBK
• UDI-Device Identifier: 10884521077096
• UDI-Public: 10884521077096
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: 840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1