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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. AIRSEP FREESTYLE; CONCENTRATOR, OXYGEN, PORTABLE
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CAIRE INC. AIRSEP FREESTYLE; CONCENTRATOR, OXYGEN, PORTABLE Back to Search Results
Model Number AS095-101
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
The device has been returned for evaluation.If any new information is discovered, a follow up mdr will be submitted.
 
Event Description
The company was informed on (b)(6) 2018 of an adverse event that occurred on (b)(6) 2018.Insufficient oxygen concentration of the unit almost caused the death of a patient.This unit was involved in another incident, reported in 3004972304-2018-00058.
 
Manufacturer Narrative
Unit was returned for evaluation.The unit did not show any external signs of damage on the packaging or exterior.The only damage noticed was a pinched battery communication wire inside the unit.All accessories included did not show any damage.The unit did not produce any smoke or abnormal smells.However, the unit produced an oxygen concentration lower than the 87-95.5% specification at all settings.The pressure profile of the unit followed the normal curve.There were no leaks found on the unit.The suspected cause of the low oxygen concentration is deficient sieve beds.
 
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Brand Name
AIRSEP FREESTYLE
Type of Device
CONCENTRATOR, OXYGEN, PORTABLE
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
MDR Report Key8204554
MDR Text Key131697147
Report Number3004972304-2018-00057
Device Sequence Number1
Product Code CAW
Combination Product (y/n)N
PMA/PMN Number
K020324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberAS095-101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
Date Manufacturer Received12/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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