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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 Fire (1245)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2019
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
(b)(6) reported that the unit was sitting in a check room, and it caught on fire.
 
Manufacturer Narrative
The unit was returned for an evaluation.Based on the concentrated damage found on the pcb assembly and on the unit's front cover, it can be determined that the fire originated internally from the motor control board.A short circuit between components on the board could have caused the mosfet voltage amplifier to fail and start a fire.The soot found on the inside of the front cover suggests that the fire burned internally before melting the plastic features of the unit's front cover.The unit's other subassemblies were found undamaged.
 
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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 Key9578331
MDR Text Key174593115
Report Number3004972304-2020-00002
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 02/05/2020
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 Manufacturer12/30/2019
Initial Date Manufacturer Received 12/12/2019
Initial Date FDA Received01/10/2020
Supplement Dates Manufacturer Received12/12/2019
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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