MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; WINNER EVO CM4 WITHOUT APPLICATOR

Model Number 410-012

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The end-user has a device that seems to be not working.When you turn it on, there is a smell coming from the machine that smells like burning electronics.This is just as the machine is on and not that you have programmed in anything such as stim or us.The screen seems to be fine, but the athletic trainer at the school said he thought he saw smoke coming from the vent at the top.

Event Description

The device was returned for repair.Confirmed there was a burning smell coming from the unit and the fan was not running.There was a capacitor on the ultrasound board that burnt up causing the smoke and buring smell also the burnt up capacitor caused the fan to go out due to the unit not operationable the unit was shut off and repaired before the stim side was tested.After the ultrasound board was replaced the unit was tested and passed all functional tests.The decal on the front of the unit was damaged from excessive heat in the top right corner so the decal was replaced.The applicator was tested than calibrated.

• Brand Name: RICHMAR
• Type of Device: WINNER EVO CM4 WITHOUT APPLICATOR
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• MDR Report Key: 9191773
• MDR Text Key: 209805730
• Report Number: 3012316249-2019-00035
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 410-012
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1