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 Burn(s) (1757)

Event Date 01/30/2022

Event Type  Injury  

Event Description

On january 25, 2022, caire received a report of the below incident from (b)(6): the patient went into his bathroom at his residence and attempted to light a cigarette while wearing an oxygen nasal cannula, which resulted in a fire.The patient sustained burns to his right side of face, jaw, nose, ear, and left knee.The patient was taken to the emergency department for evaluation and treatment and was released.

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.The user manual contains warnings to not smoke while using the device, and the device labeling includes warning symbols to not smoke while using the device.

• 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: 13909623
• MDR Text Key: 288139224
• Report Number: 3004972304-2022-00010
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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: BED; E CYL X4; NEBULIZER; OBT; SUCTION RESPIRATORY; WHEELCHAIR TRANSPORT 19 IN.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White