MAUDE Adverse Event Report: CAIRE INC. CAIRE NEWLIFE INTENSITY 10; CONCENTRATOR, OXYGEN, STATIONARY

Model Number AS099-100

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

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

Event Date 04/09/2017

Event Type  Injury  

Manufacturer Narrative

The provider has refused to return the unit for inspection.

Event Description

The company was informed on may 8, 2017 of an event that occurred on (b)(6) 2017.The patient stated to his provider that he decided to smoke a cigarette without removing his oxygen or turning off the oxygen concentrator.The patient stated that his oxygen tubing caught on fire and he burned both nostrils and upper lip.These were second degree burns.

• Brand Name: CAIRE NEWLIFE INTENSITY 10
• Type of Device: CONCENTRATOR, 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: 6605875
• MDR Text Key: 76448528
• Report Number: 3004972304-2017-00010
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS099-100
• Device Catalogue Number: AS099-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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
• Patient Outcome(s): Other