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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY; UNIT, FLUIDOTHERAPY
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DJO, LLC CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY; UNIT, FLUIDOTHERAPY Back to Search Results
Model Number FLU115D
Medical Device Problem Code Smoking (1585)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 09/30/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.
 
Event or Problem Description
It was reported that the machine was found to be smoking.They moved it outside and could not get the corn media to stop smoldering so they dumped water on it.The machine was found plugged into the wall but not turned on.It was reported to not have been used the prior day.It had allegedly created a lot of corn dust/particulate in the previous months.There was no patient involvement / harm.No further information is currently available.
 
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Brand Name
CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY
Common Device Name
UNIT, FLUIDOTHERAPY
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081 9663
MDR Report Key9226968
Report Number9616086-2019-00077
Device Sequence Number18876409
Product Code LSB
UDI-Device Identifier00190446305149
UDI-Public00190446305149
Combination Product (Y/N)N
Initial Reporter StateMT
Initial Reporter CountryUS
PMA/510(K) Number
K011243
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberFLU115D
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2019
Initial Report FDA Received Date10/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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