MAUDE Adverse Event Report: CAIRE INC. COMPANION 41; UNIT, LIQUID OXYGEN, STATIONARY

Model Number B-700895-00

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2017

Event Type  malfunction  

Manufacturer Narrative

The unit is being returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

This report was originally submitted on 08-25-2017, and is being resubmitted on 03-06-2020 as the original submission failed to go through.The fire caught in the middle of the vent pipe (cannula) when the patient started the ventilation (using a ventilator).The oxygen at 3l/mn was coupled to the ventilation mask.The patient set the 02 flow to zero.The fire did not spread.The patient is not injured.The patient no longer smokes.He used an aerosol insecticide before the incident.

• Brand Name: COMPANION 41
• Type of Device: UNIT, LIQUID OXYGEN, STATIONARY
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7707217700
• MDR Report Key: 7039279
• MDR Text Key: 188082244
• Report Number: 3004972304-2017-00023
• Device Sequence Number: 1
• Product Code: BYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K830498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: B-700895-00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: No
• 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