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U.S. Department of Health and Human Services

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

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CAIRE INC. VISIONAIRE OXYGEN CONCENTRATOR OXYGEN CONCENTRATOR, STATIONARY Back to Search Results
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.

 
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Brand NameVISIONAIRE OXYGEN CONCENTRATOR
Type of DeviceOXYGEN 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 Key5614778
MDR Text Key43884100
Report Number3004972304-2016-00007
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK872534
Number of Events Reported1
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 Received04/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberVISIONAIRE
Device Catalogue NumberAS098-1
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2016
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 Unkown

Patient TREATMENT DATA
Date Received: 04/28/2016 Patient Sequence Number: 1
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