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

Model Number AS099-101

Device Problem Fire (1245)

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

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Unit has not been returned for evaluation.Customer is not responding.Three attempts have been made to get the unit back.If any new information is discovered, a follow-up mdr will be submitted.

Event Description

Patient was smoking while using oxygen, causing a fire and the patient to sustain third degree burns on his face, in his nares, left armpit and on his left side.He took himself to the urgent care center for treatment and returned home with silvadene cream treatment to the burns.

• Brand Name: 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
• MDR Report Key: 8697731
• MDR Text Key: 147951784
• Report Number: 3004972304-2019-00037
• 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: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AS099-101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR