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

Model Number AS099-101

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/03/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was smoking while using the oxygen concentrator.The user manual and device labeling includes warnings to not smoke while using the concentrator.The device has not been returned to caire for an evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

The patient lit a cigarette while o2 was on via nasal cannula at 10 lpm.Fire flew into her face, and she sustained second degree burns to her hands and face.

• 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: pamela netzel ; 2200 airport industrial drive; suite 500; ball ground, GA 30107 ; 7169499810
• MDR Report Key: 13372583
• MDR Text Key: 285574324
• Report Number: 3004972304-2022-00005
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/27/2022

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: AS099-101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2019
• 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
• Treatment: ECILINDER; MCILINDER; NEBULIZER COMPRESSOR; WALKER ROLLATOR
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 37 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White