MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA LEGEND XT 4CH COMBO PKG, US STD, 5CM APPL; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2788
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.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 "unit is turning off/ or changing settings on its own mid use." there was reportedly no patient harm.No further information is currently available.

• Brand Name: CHATTANOOGA LEGEND XT 4CH COMBO PKG, US STD, 5CM APPL
• Common Device Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9864811
• Report Number: 9616086-2020-00011
• Device Sequence Number: 3268126
• Product Code: IMG
• UDI-Device Identifier: 00888912294188
• UDI-Public: 00888912294188
• 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): 03/22/2020

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: 2788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1