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

Model Number	840 VENTILATOR
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an 840 ventilator had a blank upper display.There was no patient involvement at the time of the reported incident.The service engineer replaced the backlight assembly.The ventilator was in working condition.
Additional Manufacturer Narrative
A graphical user interface (gui) backlight assembly was returned to covidien/medtronic¿s product analysis.A visual inspection found no notable conditions.An investigation was performed and the product analysis technician reported that no fault was found.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A graphical user interface (gui) flex cable was returned to covidien/ medtronic¿s product analysis.A visual inspection of the returned component was performed, no notable conditions were found.A continuity test was carried out on all of the pins of the cable; no anomalies were observed.An investigation was performed and the product analysis technician reported that no fault was found.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: 6751871
• Report Number: 8020893-2017-07169
• Device Sequence Number: 19052881
• Product Code: CBK
• UDI-Device Identifier: 10884521077034
• UDI-Public: 10884521077034
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/08/2018

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 VENTILATOR
• Device Catalogue Number: 4-840220DIEC-IT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 07/11/2017; 01/04/2018
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 09/01/2017; 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1