MAUDE Adverse Event Report: COVIDIEN 840 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 840

Device Problem Occlusion Within Device (1423)

Patient Problem No Code Available (3191)

Event Date 05/24/2017

Event Type  Injury  

Event Description

It was reported while in use on a patient, an 840 ventilator generated a severe occlusion alarm.No other information is available at this time.Covidien was not authorized to service the device.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: 840 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer (Section G): COVIDIEN; micheal collins rd mervue; galway
• Manufacturer Contact: ray maroofian ; 2101 faraday av.; carslabad, CA 92008 ; 7606035334
• MDR Report Key: 6640532
• MDR Text Key: 77549482
• Report Number: 8020893-2017-06571
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

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: 840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 05/24/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2006
• 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): Other