MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The technical support engineer (tse) troubleshot the issue with the customer over the phone; the customer to replace the graphic user interface (gui) printed circuit board (pcb).

Event Description

It was reported that the ventilator's upper display has lines.The ventilator was not on a patient at the time of the event.

Manufacturer Narrative

A pressure solenoid (psol) and graphic user interface (gui) printed circuit board (pcb) were returned to covidien/medtronic¿s product analysis.A visual inspection of the returned components was performed, contamination was found on the concentric circles of the poppet on the psol and no anomalies were found on the gui pcb.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 psol root cause was isolated to the contamination.The gui pcb root cause was isolated to a component (video graphics array controller u34) on the xena i pcb.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The device was repaired and the reported problem was isolated to contamination by foreign material.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer (Section G): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5722627
• MDR Text Key: 47424722
• Report Number: 8020893-2016-01402
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970460
• 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,Followup
• Report Date: 12/20/2017

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
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 10049998
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: 09/12/2017; 09/12/2017
• Supplement Dates FDA Received: 09/28/2017; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2011
• 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