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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. FREESTYLE 3; OXYGEN CONCENTRATOR, PORTABLE
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CAIRE INC. FREESTYLE 3; OXYGEN CONCENTRATOR, PORTABLE Back to Search Results
Model Number AS095-101
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2019
Event Type  malfunction  
Manufacturer Narrative
The device was returned for an evaluation.If any new information is discovered, a follow-up report will be submitted.
 
Event Description
This report was originally submitted on 12-17-2019, and is being resubmitted on 3-10-2020 as the original submission failed to go through.The unit was located with a distributor at the time of the incident.The unit was sitting in a check room and started smoking.The unit was not with a patient, and there was no injury.
 
Manufacturer Narrative
The unit was returned for evaluation.Based on the damage found on the motor control board, it can be determined that the reported fire originated there.A short circuit between components on the board could have caused the two mosfet voltage amplifiers to fail and start a fire.All fire damage was contained to the motor control board.Besides some superficial corrosion on the sieve beds and compressor assembly, the unit's other subassemblies were found intact.
 
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Brand Name
FREESTYLE 3
Type of Device
OXYGEN CONCENTRATOR, PORTABLE
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
MDR Report Key9813264
MDR Text Key182786315
Report Number3004972304-2020-00003
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 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberAS095-101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received03/10/2020
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received03/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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