MAUDE Adverse Event Report: CAIRE INC. COMPANION 5; STATIONARY, OXYGEN CONCENTRATOR

Model Number 15067005

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/02/2020

Event Type  Injury  

Manufacturer Narrative

The unit has not been returned for an evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

The patient was smoking while using oxygen and forgot to remove the cannula.There was a flash fire that caused the patient to sustain second degree burns to his face.The patient notified the healthcare office in the morning, and a nurse was sent out to perform an assessment.The patient was not complaining of shortness of breath or inability to breathe.The nurse provided treatment for the burn, and the patient is using supplemental oxygen at 4 lpm.The patient was educated not to smoke while using oxygen.

• Brand Name: COMPANION 5
• Type of Device: STATIONARY, OXYGEN CONCENTRATOR
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground, ga
• Manufacturer (Section G): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground, ga
• Manufacturer Contact: neal maloy ; 2200 airport industrial drive; suite 500; ball ground, ga ; 7217700
• MDR Report Key: 10038314
• MDR Text Key: 190319727
• Report Number: 3004972304-2020-00014
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/08/2020

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: 04/09/2020
• Initial Date FDA Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 63