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

Model Number	840
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an 840 ventilator had a screen blocked error while in use on a patient.The patient was removed from the ventilator and placed on a second ventilator.The patient was not harmed or injured as a result of the event.The service engineer (se) verified the malfunction and replaced the graphical user interface (gui) touch frame printed circuit board (pcb).The unit passed all testing and operates within the manufacturing specifications.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2017 stating that the original notification date and event date were on (b)(6) 2017.Updated the event date and the notification date was corrected to (b)(6) 2017.
Additional Manufacturer Narrative
Product analysis: a touch frame printed circuit board (pcb) was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed and areas of contamination were found on the pcb that was fluid ingress originating from cleaning products entering the graphic user interface housing.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 product analysis technician reported that the root cause was isolated to the touch frame contamination.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: 6443166
• Report Number: 8020893-2017-05452
• Device Sequence Number: 976741
• 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): 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided; 06/12/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 06/28/2017; 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention