MAUDE Adverse Event Report: DJO LLC CHATTANOOGA; THERATHERM MOISTHEAT PAD SHLDR

Catalog Number	1033
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that it was reported that there was a fire due to possible malfunction of the device.
Additional Manufacturer Narrative
It was reported that there was a fire due to possible malfunction of the device reporter stated "it was determined that this fire likely originated at the heating pad that was in use in the master bedroom.No defect with the building services was identified.The electrical failure of the power cord was likely a result of the fire.This fire was likely caused by a failure of the heating pad, causing the heating pad to overheat, igniting the pad, and other nearby combustibles." device was not returned for evaluation.The root cause could not be established.If more information becomes available additional reporting on this event will be provided as a supplemental report to this document.

• Brand Name: CHATTANOOGA
• Common Device Name: THERATHERM MOISTHEAT PAD SHLDR
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 20604981
• Report Number: 9616086-2024-00103
• Device Sequence Number: 15290278
• Product Code: IRT
• UDI-Device Identifier: 00888912000154
• UDI-Public: 00888912000154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: D086569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 1033
• Device Lot Number: 130310330331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown