MAUDE Adverse Event Report: CAIRE INC. VISIONAIRE OXYGEN CONCENTRATOR; OXYGEN CONCENTRATOR, STATIONARY

Model Number VISIONAIRE

Device Problems Fire (1245); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/24/2016

Event Type  Death  

Manufacturer Narrative

The unit is being kept at the facility where the incident occurred until the manufacturer, provider, nursing home and attorney can supply expert witnesses to attend.Once a date is selected, the testing of the unit will commence.

Event Description

The company was notified on (b)(4) 2016 of an event that occurred on (b)(6) 2016 involving a visionaire oxygen concentrator.The unit was present at the scene of a fire that resulted in the death of the patient.There is no information on the cause of the fire.

Manufacturer Narrative

The provider inspected the unit but the company was not included in the inspection.The results were communicated to the company after the inspection.There was debris taken from the scene that included smoking materials including an ashtray, remnants of an e-cigarette, and other items.The inspection showed that there was nothing wrong with the concentrator.The fire originated at the patient end of the cannula and moved toward the concentrator.The unit explicitly states that there should be no smoking while using the unit or around the unit.

Event Description

The company was notified on february 3, 2016 of an event that occurred on (b)(6) 2016 involving a visionaire oxygen concentrator.The unit was present at the scene of a fire that resulted in the death of the patient.There is no information on the cause of the fire.

• Brand Name: VISIONAIRE OXYGEN CONCENTRATOR
• Type of Device: OXYGEN CONCENTRATOR, 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 ; 7707217712
• MDR Report Key: 5614778
• MDR Text Key: 43884100
• Report Number: 3004972304-2016-00007
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K872534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: VISIONAIRE
• Device Catalogue Number: AS098-1
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR