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

Model Number	840
Medical Device Problem Codes	No Display/Image (1183); Device Inoperable (1663)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, an 840 ventilator had a blank display.Patient involvement information was not provided.The service engineer (se) verified the malfunction and replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the software to the latest revision.The unit passed all testing and operates within the manufacturing specifications.
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 failed the power on self-test (post).The ventilator exhibited a loud whistle and the display screen was black.There was no patient involvement at the time of the reported condition.The service engineer (se) verified the malfunction.The se replaced the graphical user interface (gui) printed circuit board (pcb) and upgraded the software to the latest revision.The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
The device was repaired and the reported issue was isolated to interface between the device and the failed component.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: 6447042
• Report Number: 8020893-2017-05484
• Device Sequence Number: 1577234
• Product Code: CBK
• UDI-Device Identifier: 10884521077188
• UDI-Public: 10884521077188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K970460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2017

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: 4-840220DRAC-GR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided; 03/02/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 04/19/2017; 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1