MAUDE Adverse Event Report: ZYNEX MEDICAL INC ZYNEX; NEXWAVE

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

Patient Problem Electric Shock (2554)

Event Date 10/03/2013

Event Type  malfunction  

Event Description

Unit gets hot.Use to be able to use one battery every 24hrs, now it's 3 batteries every 24 hrs.Unit gets so hot it's unbearable.Patient is experiencing more surge shocks now.

Manufacturer Narrative

Reporting due to an fda findings during audit in 1/2015.Investigation and results; unit turned on, passed final testing without any problems.Left unit running for 30 minutes at 31ma on both channels (tens mode) and had no heat issue.Could not duplicate patients complaint.

• 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: 4574819
• MDR Text Key: 19719473
• Report Number: 1723686-2015-00001
• Device Sequence Number: 1
• Product Code: IPF
• 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: 10/11/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2011
• 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