MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; CONTINUOUS VENTILATOR

Model Number 840

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Covidien reference number: (b)(4).Service engineer (se) inspected the device and found the unit had a very high build up of moisture in the circuit and exhalation filter.The filter was replaced.The ventilator passed the all testing and was returned to service.

Event Description

It was reported that during patient use, the ventilator exhalation valve was sticky.The patient was transferred to another ventilator with no harm.The customer reported that a medication (flolan) was being administered via a nebulizer at the time of the event occured.

• 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: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6071465
• MDR Text Key: 58915085
• Report Number: 8020893-2016-02940
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2016

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: 10049998
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2011
• 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