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

Model Number	AS099-100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
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(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 or Problem Description
As reported: patient attempted to smoke while wearing his oxygen and sustained second degree burns to bilateral nares.He went to bed and woke up at 4am having difficulty breathing and called 911 to take him to the hospital for treatment.Patient is a known smoker.
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.

• Brand Name: NEW LIFE INTENSITY 10
• 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: 19968073
• Report Number: 3004972304-2024-00002
• Device Sequence Number: 8801371
• Product Code: CAW
• UDI-Device Identifier: M766AS0991010
• UDI-Public: +M766AS0991010/16D20180419M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K960309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• 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: AS099-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2018
• 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
• Patient Age: 64 YR
• Patient Sex: Male