MAUDE Adverse Event Report: CAIRE INC. COMPANION 5; CONCENTRATOR, OXYGEN, STATIONARY

Model Number 15067005

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/06/2023

Event Type  Injury  

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.

Event Description

As reported: patient was sitting in her dining room with her oxygen on and was smoking a cigarette, which caused a flash fire to her face.Patient's family smelled smoke and ran to find the patient.Family put out the flames with a wet cloth.Patient's caregiver called 911 and the hospice nurse who went to the home.Nurse facetimed with hospice doctor while awaiting ems.Ems arrived and patient was air flighted to (b)(6) center for treatment.Patient was diagnosed with partial thickness burns to the forehead nose and left aspect of the neck.Patient is admitted to hospice with a primary diagnosis of chronic obstructive pulmonary disease a related diagnosis of dyspnea and an unrelated diagnosis of hyperlipidemia.Patient has denied that she is a smoker to hospice team.

• Brand Name: COMPANION 5
• 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: 18231149
• MDR Text Key: 329315634
• Report Number: 3004972304-2023-00018
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121167
• 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: 15067005
• 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: 08/12/2019
• 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
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White