MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The service engineer (se) evaluated the ventilator and replaced the liquid crystal display (lcd)panel, which resolved the reported issue.The ventilator passed self-testing.

Event Description

It was reported that, during use on a patient an 840 ventilator had lines across the display.Patient was removed from the ventilator and placed on an alternate ventilator.There was no report of patient harm as a result of the event.

• 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 hamspshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5439166
• MDR Text Key: 38282586
• Report Number: 8020893-2016-00354
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2016

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
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 4-840220DIPC-PL
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2015
• Initial Date FDA Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/1999
• 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
• Patient Outcome(s): Required Intervention