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U.S. Department of Health and Human Services

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

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CAIRE INC. COMPANION 5 STATIONARY, OXYGEN CONCENTRATOR Back to Search Results
Model Number 15067005
Device Problems Use of Device Problem; Improper or Incorrect Procedure or Method
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.

 
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Brand NameCOMPANION 5
Type of DeviceSTATIONARY, 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 Key10038314
Report Number3004972304-2020-00014
Device Sequence Number1
Product CodeCAW
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
Date FDA Received05/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number15067005
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/07/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/08/2020 Patient Sequence Number: 1
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