MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT LEGEND XT COMBOUS STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2760
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/04/2019
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 during russian treatment the unit increases intensity and shocks patients, then it shuts off.No further information is currently available.

• 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): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 9117431
• Report Number: 9616086-2019-00066
• Device Sequence Number: 2974279
• Product Code: IMG
• UDI-Device Identifier: 00888912292740
• UDI-Public: 00888912292740
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 09/24/2019

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: 09/04/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1