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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. FREESTYLE 5; OXYGEN CONCENTRATOR, PORTABLE
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CAIRE INC. FREESTYLE 5; OXYGEN CONCENTRATOR, PORTABLE Back to Search Results
Model Number AS077-103
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2019
Event Type  malfunction  
Manufacturer Narrative
Unit has been returned for evaluation.If any new information is discovered, a follow-up report will be submitted.
 
Event Description
The battery would not charge and there was a burnt wire harness.There were no injuries sustained.
 
Manufacturer Narrative
The unit was returned for evaluation.The damage reported, a burnt power input wire harness, was confirmed through a visual inspection.The wire harness in question showed discoloration and burn damage that would be indicative of a power surge or a short circuit, but based on the lack of provided information on the unit, the undamaged and working condition of the included power supply, and the unit's ability to function to its specifications under battery power the cause of the malfunction could not be ascertained.Since the burn damage was concentrated to the wire harness and the unit was left functional under battery power, it indicates that the unit's built-in protections limited the damage and protected the user from risk.No injuries were reported.
 
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Brand Name
FREESTYLE 5
Type of Device
OXYGEN CONCENTRATOR, PORTABLE
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
MDR Report Key9383371
MDR Text Key188062808
Report Number3004972304-2019-00053
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 foreign
Type of Report Initial,Followup
Report Date 01/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberAS077-103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Date Manufacturer Received10/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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