MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY; UNIT, FLUIDOTHERAPY

Model Number FLU115D

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2019

Event Type  malfunction  

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 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.

• Brand Name: CHATTANOOGA FLUIDTHERAPY DOUBLE EXTREMITY
• Type of Device: UNIT, FLUIDOTHERAPY
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana,
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9226968
• MDR Text Key: 163402787
• Report Number: 9616086-2019-00077
• Device Sequence Number: 1
• Product Code: LSB
• UDI-Device Identifier: 00190446305149
• UDI-Public: 00190446305149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLU115D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1