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

Model Number AS005-1

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 08/10/2016

Event Type  Injury  

Manufacturer Narrative

We were unable to duplicate the customer complaint, unit meets specification requirements.The unit operated overnight with no problems.By visual observation there is no evidence of fire damage.The unit had a strong cigarette smoke odor indicating the unit was most likely exposed to cigarette smoke.There was no problem found with the unit.There are no signs that the fire originated from the unit.There is no internal or external damage to the concentrator or any of the components from fire.

Event Description

The company was notified on august 12, 2016 of an adverse event that occurred in (b)(6).The provider disclosed that the user regularly smokes.It appeared that the user fell asleep while smoking on oxygen.The cigarette touched the cannula and it ignited.The user went to the emergency room and was released the same day with a 3rd degree burn to side and hand.There is a possibility that there were some first degree burns as well.

• Brand Name: NEWLIFE ELITE
• 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: 5943699
• MDR Text Key: 54470796
• Report Number: 3004972304-2016-00026
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS005-1
• Device Catalogue Number: AS005-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 55 YR