MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW; LAMP, INFRARED, THERAPEUTIC HEATING

Model Number	27812
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One laser applicator (part number 27812, serial number (b)(4)) was returned along with vectra genisys base unit (part number 2784, serial number (b)(4)).No fault was found with the base unit; the product met specifications and did not malfunction.The laser applicator was observed to have a dirty / scratched lens, the laser printed handle was not flush, and the calibration sticker was not from djo.Functional test yielded an error 201: laser output too high.This followed with checks yielding results of "five lasers ok" for laser only tests (1190 mw, 1180 mw).No issues were found when opening the head and bottom cable to check for alterations and damaged wires.The laser applicator has been in the field for 5+ years with no annual calibration.A definitive root cause to the reported event cannot be conclusively determined.
Event or Problem Description
It was reported that the patient "got a sensation of being burned, caused blisters and irritation on patient".No further information was provided.

• Brand Name: CHATTANOOGA APPLICATOR 9CLS 5X200MW 1040MW
• Common Device Name: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 8772707
• Report Number: 3012446970-2019-00019
• Device Sequence Number: 2296506
• Product Code: ILY
• UDI-Device Identifier: 00888912293853
• UDI-Public: 00888912293853
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040662
• 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): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/09/2019
• 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: Required Intervention