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

Model Number AS099-100

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

Patient Problem Burn(s) (1757)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

The company is attempting to have the unit returned.If the unit is returned and evaluated, or if any additional information is discovered, a followup report will be submitted.

Event Description

The company was notified on august 12, 2016 of an adverse event that occurred in (b)(6).The user lit a cigarette while on oxygen.The user was on 5lpm; he forgot that the oxygen was on and lit a cigarette.This resulted in a flash fire which ignited a blanket.The user went to the hospital with burns to the face and hands.

• Brand Name: NEWLIFE INTENSITY 10
• 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: 5943692
• MDR Text Key: 54472538
• Report Number: 3004972304-2016-00025
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

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
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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