MAUDE Adverse Event Report: CAIRE INC. NEWLIFE INTENSITY 8L; CONCENTRATOR, OXYGEN, STATIONARY

Model Number AS094-100

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/09/2021

Event Type  Injury  

Event Description

Second degree burns to bilateral nostrils and face while smoking with o2 on.

Manufacturer Narrative

Caire is attempting to have the unit returned for an evaluation.If any new information is discovered, a follow-up report will be submitted.

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 device was returned to caire for an evaluation.The unit was not operational upon arrival and was in a disheveled state.A visual inspection did not reveal any burn marks or potential malfunctioning components.The cause of the broken wire to the run capacitor is unknown.The incident reported is that the patient received burns to their nostrils and face while smoking with the oxygen concentrator on.The manual for this unit includes a statement of not smoking near the device.

• Brand Name: NEWLIFE INTENSITY 8L
• 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: 13317396
• MDR Text Key: 285649945
• Report Number: 3004972304-2022-00003
• 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,Followup
• Report Date: 03/30/2022

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: AS094-100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2006
• 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: CYLINDER TANKS.; CYLINDER TANKS.; NEBULIZER.; REGULATOR.; TANK CART.; TANK RACK.
• Patient Outcome(s): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White