MAUDE Adverse Event Report: COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840 VENTILATOR; CBK; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problem Sticking (1597)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

Customer reported that an 840 ventilator graphical user interface (gui) keypad key was stuck.The device was not being used on a patient when the event occurred.The covidien technical support engineer (tse) troubleshot the issue with the customer over the phone.

Manufacturer Narrative

(b)(4).The customer stated that reported event could not be duplicated.Covidien was not authorized to service the device.

• Brand Name: 840 VENTILATOR
• Type of Device: CBK; VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer (Section G): COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND; new mervue industrial park; michael collins road; galway ; EI
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 3829938
• MDR Text Key: 4403937
• Report Number: 8020893-2014-00538
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/13/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2004
• 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