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 service engineer (se) evaluated the ventilator, and verified the customer reported malfunction.The se replaced the graphic user interface (gui) printed circuit board (pcb), the backlight inverter printed circuit boards (pcbs), and uploaded the latest software revision to resolve the issue.The ventilator passed all tests and calibrations, and it was found to be operating within manufacturing specifications.

Event Description

It was reported that a ventilator lower display exhibited horizontal lines and unusual colors.There was no patient involvement.

• 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: 5275094
• MDR Text Key: 33350398
• Report Number: 8020893-2015-01677
• 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
• Report Date: 11/16/2015

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: 840
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2015
• Initial Date FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/1999
• 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