MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX; TRUWAVE

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

Patient Problem No Information (3190)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

Patient states when charging the battery, sparks started coming from the circuit board above the battery, a fire started, smoked the house and patient removed battery/disconnected electrodes.

Manufacturer Narrative

Reporting due to fda findings during audit in 01/2015.Investigation and results: unit powered on, passed final testing without any problems.Could not duplicate patients problem or incident description.No problem found.

• Brand Name: ZYNEX
• Type of Device: TRUWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO 80120
• Manufacturer Contact: 9990 park meadows dr; lone tree, CO 80120 ; 8004956670
• MDR Report Key: 4574774
• MDR Text Key: 19352820
• Report Number: 1723686-2015-00007
• 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: 02/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2009
• 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