MAUDE Adverse Event Report: CAIRE INC. NEWLIFE INTENSITY; 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 11/08/2023

Event Type  Injury  

Event Description

As reported: patient was smoking with oxygen on resulting in an oxygen explosion.Patient sustained burn erythema of face and head, partial thickness burn of right cheek, partial thickness burn of left cheek, partial thickness burn of left great to,e partial thickness burn of right great toe, partial thickness burn of multiple sites of right hand, and partial thickness burn of multiple sites of left hand.She had singed hair, obvious charring, and blackened soot on face, singed nasal hairs, and soot noted on the back of her throat.Patient was transferred to orlando regional medical center.No known drug allergies.Patient's hospice diagnosis is chronic obstructive pulmonary disease and chronic respiratory failure.Patient is a smoker.She has a history of sedative hypnotic or anxiolytic dependence, hypertension, anxiety disorder, moderate protein-calorie malnutrition, emphysema, gastroesophageal reflux disease without esophagitis, chronic sinusitis, migraines, spondylosis without myelopathy or radiculopathy, immunodeficiency, chronic viral hepatitis c, and hemorrhagic condition.

Manufacturer Narrative

Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.The information provided represents the best information available to caire.The device(s) will not be available for engineering evaluation.The end user reported smoking a cigarette while using the device.No smoking warnings on the equipment and in the ifu were reviewed and deemed adequate in the course of the investigation."no smoking" symbols (reg# p002) are affixed to the face of the units.Throughout the unit ifu, warnings state not to allow smoking or open flame near the device and to keep all flammable materials away from the equipment.Additional warnings state that smoking while wearing an oxygen cannula can cause facial burns and possibly result in death.

• Brand Name: NEWLIFE INTENSITY
• 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
• MDR Report Key: 18231161
• MDR Text Key: 329281301
• Report Number: 3004972304-2023-00019
• 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,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• 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
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• 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): Life Threatening; Hospitalization
• Patient Age: 61 MO
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White