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

Model Number 840

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported differ parameters on 840 ventilator.The ventilator was not in use on a patient at the time the malfunction occurred.The covidien service engineer (se) inspected the device and found expiratory filter occluded.The se replaced the expiratory filter and during testing the o2 sensor was found faulty, o2 sensor will be replaced.

Manufacturer Narrative

Additional information was received from 3rd party service provider stating that during ventilator evaluation was found that the expiratory filter was occluded.Expiratory filter will be replaced by 3rd party service provider.Medtronic/covidien was not authorized to evaluate and service the device.Faulty oxygen sensor reported on initial medwatch was handled on regulatory report # 8020893-2017-06664.If information is provided in the future, a supplemental report will be issued.

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 ave.; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6656218
• MDR Text Key: 78023513
• Report Number: 8020893-2017-06663
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077133
• UDI-Public: 10884521077133
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K970460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2017

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: 4-840220DIUA-EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 05/30/2017; 05/30/2017
• Supplement Dates FDA Received: 08/17/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1