MAUDE Adverse Event Report: ZYNEX MEDICAL INC ZYNEX; NEXWAVE

Device Problems Charred (1086); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

Patient states he has been burned by the unit where he is treating the back of his left thigh.

Manufacturer Narrative

Reporting due to fda findings during audit in 01/2015.Investigation and results: patient did not return ac adapter and lead wires.Unit turned on, passed final testing without any problems.Left the unit running for 30 minutes (undisturbed).While observing the unit i did not notice any spikes or output changes that could cause a burn or shock.Could not duplicate patients complaint.No problem found.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL INC; lone tree CO 80124
• Manufacturer Contact: 9990 park meadows dr; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 4574817
• MDR Text Key: 5547486
• Report Number: 1723686-2015-00004
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other