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

Model Number AS098-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

The unit has been requested to be returned, but the request has been denied.The company will continue to request the unit for return and inspection.If further information is gathered regarding this case, a followup report will be submitted.User facility will not return.

Event Description

The company was informed on september 13, 2016 of an adverse event that occurred on (b)(6) 2016 involving a visionaire oxygen concentrator.The incident was described to the company as the patient lit a cigarette while wearing a nasal cannula at 3lpm.The patient reported once he lit the cigarette, flames immediately burned his face.The patient was transported to the hospital and discharged the next day.

• Brand Name: VISIONAIRE
• 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: 6020468
• MDR Text Key: 57146867
• Report Number: 3004972304-2016-00032
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS098-1
• Device Catalogue Number: AS098-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2015
• 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): Hospitalization