MAUDE Adverse Event Report: ZYNEX MEDICAL ZYNEX; NEXWAVE

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2013

Event Type  malfunction  

Event Description

Patient called and his unit got hot and started to smell like sulfur and burning smell.Then unit shuts off and doesn't turn on at all.

Manufacturer Narrative

Reporting due to an fda finding during an audit in (b)(4) 2014.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL; lone tree CO
• Manufacturer Contact: 9990 park meadows dr.; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 4330049
• MDR Text Key: 5131939
• Report Number: 1723686-2014-00007
• 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
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other