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 Superficial (First Degree) Burn (2685)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was smoking with the cannula on after recently turning off the oxygen concentrator.The user manual and device labeling includes warnings to not smoke while using the concentrator or while wearing an oxygen cannula.The patient was hospitalized due to covid-19, not as a result to the incident.While at the hospital, they determined that he did not suffer any additional injuries.The device has not been returned to caire for an evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

The wife called (b)(4) at 08:30 and stated that at midnight her husband wanted a cigarette.She stated she turned off the oxygen concentrator, but did not remove the nasal cannula from his nostrils.When he lit the cigarette, there was a flash fire.The patient received superficial burns to his lips, left side of mouth, and left side of face.

• 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 ; 7169499810
• MDR Report Key: 13388945
• MDR Text Key: 285574283
• Report Number: 3004972304-2022-00006
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830498
• 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: 01/28/2022

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: 15067005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: E CYLINDER; HOSPITAL BED; NEBULIZER; PATIENT LIFT/SLING; PRM; SHOWER CHAIR
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White