MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; INTELECT TRANSPORT COMBO PKG US STD

Model Number	2738
Medical Device Problem Codes	High impedance (1291); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Full thickness (Third Degree) Burn (2696); Lead(s), Burn(s) From (3161)
Date of Event	02/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Not returned.
Event or Problem Description
Complaint received that alleges "patient,"was on the machine for approx.15 minutes without incident and there was a sudden surge that shot the electrode off of his leg.When she looked at his leg he had what appears to be 3rd degree electrical burns underneath".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.
Additional Manufacturer Narrative
Product was returned for review.The unit and applicator passed functional testing.The electrodes that were sent in expired 10/2016.Two of the electrodes tested above the tolerance level.The high impedance on the electrodes may have contributed to the event.

• Brand Name: CHATTANOOGA
• Common Device Name: INTELECT TRANSPORT COMBO PKG US STD
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 6368197
• Report Number: 9616086-2017-00006
• Device Sequence Number: 1031343
• Product Code: GZI
• UDI-Device Identifier: 00888912021883
• UDI-Public: 00888912021883
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other