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

Model Number AS099-100

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

If any new information is discovered, a followup report will be submitted.

Event Description

Patient smoked a cigarette while wearing his nasal cannula at 3 liters which was connected to the oxygen concentrator.This resulted in a flash fire.The patient sustained 1st and 2nd degree burns to his cheeks, the tip of his nose, the upper left arm, his right middle finger and two spots on left hand.Patient was transported to the emergency room for evaluation.Patient was treated and released back to home.The provider ran the unit and determine the unit was operating fine and stated user error.The unit is now stored in quarantine at the provider's facility.Provider refused to send unit back to chart.

• Brand Name: 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: 6802543
• MDR Text Key: 82981132
• Report Number: 3004972304-2017-00022
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS099-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 69 YR
• Patient Weight: 68