MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Sticking (1597)

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

Event Date 01/01/2014

Event Type  malfunction  

Event Description

Covidien customer support engineer (cse) reported a stuck graphical user interface (gui) key.The malfunction did not occur during patient use.

Manufacturer Narrative

The covidien customer support engineer (cse) inspected the device and verified the reported issue.The cse replaced the keyboard, which resolved the reported issue.(b)(4).

• Brand Name: 840 VENTILATOR
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): COVIDIEN; new mervue industrial pa; galway ; EI
• Manufacturer (Section G): COVIDIEN; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: denise braxton ; 6135 gunbarrel avenue; boulder, CO 80301 ; 3038768989
• MDR Report Key: 4059874
• MDR Text Key: 4812682
• Report Number: 8020893-2014-02012
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2014

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: 07/23/2014
• Initial Date FDA Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2002
• 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