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  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that, an 840 ventilator had an occlusion alarm.The ventilator was not in use on a patient at the time the event occurred.The covidien tech support engineer (tse) troubleshot this issue with the customer over the phone and recommended replacing inspiratory filter.The customer followed the tse recommendations and the inspiratory filter was replaced.The unit passed all testing and operated within the manufacturing specifications.Covidien was not authorized to service the device.

• 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: 6758491
• MDR Text Key: 81562983
• Report Number: 8020893-2017-07240
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 10884521077034
• UDI-Public: 10884521077034
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/03/2017

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: 4-840220DIEC-IT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2009
• 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