MAUDE Adverse Event Report: DJO, LLC COMPEX; STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Model Number	11-2137
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Serial number: requested, but unavailable.
Event or Problem Description
It was reported that there was a shortage in the compex device that caused it to catch fire and spread to the end user's kitchen table.The device was stored in the box it came in with the pads and instructional paper on top of the end user's kitchen table.The device was charged beforehand, but it was disconnected while in the box.Nothing was burned besides the kitchen table, but a lot of smoke spread throughout the house.No one was at the house during the accident except for the end user's dog, whom a veterinarian confirmed was unharmed.Firefighters were called to the scene to extinguish the fire.The involved fire department is reportedly unable to return the device.
Additional Manufacturer Narrative
The report from the responding fire department states "it appeared fire started from faulty electro muscle stimulator inside a box with papers." however, there is no evidence that a technical investigation of the device was performed.The device is not available for investigation.The end user originally stated the fire department took the device.However, when contacting the fire department, djo was informed that the device was not removed from the end user's home.The end user was then contacted and stated that the device was removed by the cleaning company and subsequently discarded.A root cause of the fire cannot be determined, nor can it be conclusively traced to the compex unit.The risk documentation and safety certifications were reviewed and found to be acceptable.

• Brand Name: COMPEX
• Common Device Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• MDR Report Key: 7939691
• Report Number: 3012446970-2018-00007
• Device Sequence Number: 16647801
• Product Code: NGX
• UDI-Device Identifier: 00888912000260
• UDI-Public: 00888912000260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170918
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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: Lay User/Patient
• Device Model Number: 11-2137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1