MAUDE Adverse Event Report: DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V. CHATTANOOGA INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT,

Model Number	2760
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2020
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 device started to smoke and it stopped working." no injury was reported.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

• Brand Name: CHATTANOOGA INTELECT LEGEND XT COMBOUS STD
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT,
• Manufacturer (Section D): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c., mx 22244 ; MX 22244
• MDR Report Key: 10326534
• Report Number: 9616086-2020-00026
• Device Sequence Number: 14014752
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/27/2020

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 Number: 2760
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1