MAUDE Adverse Event Report: ZYNEX MEDICAL INC ZYNEX; NEXWAVE

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

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/17/2014

Event Type  malfunction  

Event Description

Patient reported receiving excess stimulation when unit is powered on.Unit increases excessively in stim on it's own.

Manufacturer Narrative

Reporting due to fda findings during audit in 01/2015.Investigation and results: unit turned on, passed final testing without any problems.Left unit running for 25 minutes at 23ma (tens mode) and had no excessive increase on it's own.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: 4574818
• MDR Text Key: 5559093
• Report Number: 1723686-2015-00003
• 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: 03/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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