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

Model Number AS099-100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 09/20/2022

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 unit will not be returned for an evaluation.The patient was smoking while using the concentrator.The user manual contains warnings to not smoke while using the device.

Event Description

On october 4, 2022, caire received a voluntary medwatch form from vitas healthcare for the below incident: the patient was smoking with o2 on.The patient was transported to the hospital with second degree burns to the bilateral hands, nose, and nares.

• Brand Name: NEWLIFE INTENSITY 10
• 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: 15714273
• MDR Text Key: 302841555
• Report Number: 3004972304-2022-00038
• 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
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: AS099-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White