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

Model Number 840

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation the field service engineer (fse) verified the reported event.The fse found communication error codes upon reviewing the logs.The fse replaced the gui (graphic user interface) to bd (breath delivery) cable to resolve the issue.The ventilator passed all testing according to the manufacturer specifications and was returned to the customer for clinical use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, while in use on a patient, the 840 ventilator became inoperative with the safety valve open which indicates a loss of ventilation.The patient was removed from the ventilator and placed on an alternate ventilator.The patient was not harmed or injured as a result of the reported event.

Manufacturer Narrative

Evaluation summary: the graphical user interface (gui) to breath delivery (bd) cable was returned for failure investigation.A visual inspection of the returned cable was conducted and a slight indentation was observed on the outer insulation of the cable about 17cm from the gui connector plug, near the position where the cable would exit from the gui housing.The cable was attached to the failure investigation test ventilator for analysis.The ventilator failed to power up correctly, failing post and generating a gui inoperative condition.When the cable was manipulated, communication was restored temporarily between the gui and bd printed circuit boards indicating an intermittent break in the cable.If this fault occurred during ventilation the ethernet communications link between the bd and gui pcb's would not function.This would in turn generate a "gui inop" condition.The appropriate audio and visual alarms would enunciate.The ventilator would continue to operate at the last entered settings.There would not be a loss of breath delivery to the patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: kelly adams ; 2101 faraday avenue; carlsbad, CA 92008 ; 7606035046
• MDR Report Key: 7549823
• MDR Text Key: 109485908
• Report Number: 8020893-2018-00240
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884522019354
• UDI-Public: 10884522019354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840120DIUU-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1