MAUDE Adverse Event Report: CHATTANOOGA DJO, LLC FLUIDOTHERAPY

Model Number FLU115D

Device Problems Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 01/09/2015

Event Type  Injury  

Event Description

Patient was seen on (b)(6) 2015 for occupational therapy treatment session.Upon arrival, patient was placed in the fluidotherapy machine for 15 minutes at 115 degrees.As the patient was receiving treatment the therapist was approx 10 feet away at another workstation providing treatment to another patient.After approx 10 minutes into the treatment session he did complain that it was getting too hot and at that time the temperature was lowered to 88 degrees.He was taken out of the machine after 15 minutes and noticed that his right 5th digit (from the pip joint to the fingertip) was burned to the point that the skin was actually off the finger, burn "get" was placed on the finger with a loose fitting gauze as well.Patient was escorted to the ed for further evaluation.

• Brand Name: FLUIDOTHERAPY
• Type of Device: FLUIDOTHERAPY
• Manufacturer (Section D): CHATTANOOGA DJO, LLC; vista CA
• MDR Report Key: 4465866
• MDR Text Key: 5180698
• Report Number: MW5040428
• Device Sequence Number: 1
• Product Code: LSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLU115D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 87