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

Model Number	2738
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Sparking (2595)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Date of Event	06/14/2019
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 unit was "not always turning on or shutting off unexpectedly.The unit has a power surge and causing a spark at the electrode, no patient was injured." this reportedly occurred during treatment.No further information was provided.
Additional Manufacturer Narrative
E2, e3: unknown.H3, h6: device was returned for evaluation.The product met specifications and did not malfunction per device evaluation.Unit and applicator passed functional testing.No leadwires or electrodes were sent in for evaluation.A new leadwire kit will be sent to the customer.

• Brand Name: CHATTANOOGA INTELECT TRANSPORT COMBO PKG 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: 8775280
• Report Number: 9616086-2019-00049
• Device Sequence Number: 1977411
• Product Code: IMG
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/25/2020

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: 2738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement 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