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

Model Number	15067005
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/07/2024
Type of Reportable Event	Death
Additional 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 will not be available for engineering evaluation and the availalbe evidence indicates confirmed use error.The end user reported falling asleep while smoking a cigarette and 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 or Problem Description
As reported: patient fell asleep while smoking with oxygen on, igniting oxygen.Patient sustained grade three inhalation burns and additional partial thickness burns to hands and feet.Soot noted through the mouth and nose, and bilateral corneal abrasions.Patient taken to transferred to orlando regional medical center burn unit.Patient is currently intubated with ventilator support.Updated 17 july: patient death date (b)(6) 2024.

• Brand Name: COMPANION 5
• Common Device Name: 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: 19964481
• Report Number: 3004972304-2024-00009
• Device Sequence Number: 8674398
• Product Code: CAW
• UDI-Device Identifier: M766150670050
• UDI-Public: +M766150670050/16D20210412M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 15067005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White