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 09/01/2014

Event Type  Injury  

Event Description

Covidien received information that, during patient use, a key on the 840 ventilator keyboard was stuck.The patient was taken off the ventilator and switched to another ventilator.No harm to the patient was reported.

Manufacturer Narrative

The covidien customer support engineer (cse) evaluated the device and did not duplicate the reported issue.The cse replaced the keyboard due to a error message in the memory log.The ventilator passed self-testing.(b)(4).

• 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: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 4126435
• MDR Text Key: 4925015
• Report Number: 8020893-2014-02272
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 840
• Device Catalogue Number: 840
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/10/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2003
• 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