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 Partial thickness (Second Degree) Burn (2694)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

The unit is being requested back for investigation.Once further information has been obtained a followup report will be submitted.

Event Description

The company was notified on january 6, 2017 of an adverse event that occurred on (b)(6) 2016.The patient was smoking a cigarette with his nasal cannula next to him on the floor.He was extinguishing the cigarette and leaned down to pick up the nasal cannula.When he sat upright the nasal cannula was on fire.His shirt was on fire and he sustained burns to his face and chest.The patient's brother was at the house and assisted with extinguishing the flames and getting the burnt shirt off.The patient was taken to the hospital by his family and was treated by the hospital physician and discharged with instructions for the care of his second degree burns.

• 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: 6296431
• MDR Text Key: 66359347
• Report Number: 3004972304-2017-00002
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/06/2017

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: AS005-1
• Device Catalogue Number: AS005-1
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2004
• 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): Hospitalization; Other
• Patient Age: 55 YR
• Patient Weight: 73