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

Device Problem Intermittent Energy Output (4025)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2019

Event Type  malfunction  

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 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.

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
• Type of Device: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8969217
• MDR Text Key: 163732027
• Report Number: 9616086-2019-00062
• Device Sequence Number: 1
• Product Code: IMG
• UDI-Device Identifier: 00888912293945
• UDI-Public: 00888912293945
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 01/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1