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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHATTANOOGA (DJO GLOBAL) HYDROCOLLATOR; HOT PACK CONDITIONER
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CHATTANOOGA (DJO GLOBAL) HYDROCOLLATOR; HOT PACK CONDITIONER Back to Search Results
Model Number M-2
Device Problems Thermal Decomposition of Device (1071); Charred (1086); Fire (1245); Device Emits Odor (1425); Overheating of Device (1437); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2014
Event Type  malfunction  
Event Description
On (b)(6), staff in physical therapy reported an electrical burning smell coming from their hot pack conditioner.The biomedical equipment tech responded and did not find any problems at the time, and the burning smell had dissipated.The next morning (b)(6), it was reported that the hot pack conditioner was not working.The bmet removed the cover of the hot pack conditioner for testing and repair, and discovered that there had been a small electrical fire inside of the device.Two wires connecting the heating element show signs of heating/fire damage.The top wire shows browning and charring where it connects to the heating element.The bottom wire has been burned through and is completely severed.Neither of the two 15-amp fuses in the electrical connection blew.Pictures were taken at the time of discovery and are available.No pt harm occurred, and the fire was contained to the hot pack conditioner.
 
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Brand Name
HYDROCOLLATOR
Type of Device
HOT PACK CONDITIONER
Manufacturer (Section D)
CHATTANOOGA (DJO GLOBAL)
vista 92081
MDR Report Key3893655
MDR Text Key4677920
Report NumberMW5036773
Device Sequence Number1
Product Code IME
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM-2
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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