MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA INTELECT TRANSPORT 2CH STIM US STD; STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number	2783
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2019
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 "the intensity will stop all of a sudden, and then without warning come back on and cause an uncomfortable surge in intensity." there was no reported adverse event.No further information is currently available.
Additional Manufacturer Narrative
One intellect transport 2ch stim us std (product number (b)(4), serial number (b)(4) was returned for evaluation.The unit was received in good condition and the device passed functional testing.No fault was found.The reported problem was not confirmed.The associated device history record was reviewed and no issues related to this complaint were identified.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT 2CH STIM US 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: 8969217
• Report Number: 9616086-2019-00062
• Device Sequence Number: 16816283
• Product Code: IMG
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K040285
• 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,Followup
• Report Date (Section B): 01/20/2020

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: 2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 01/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1