MAUDE Adverse Event Report: ZYNEX MEDICAL INC ZYNEX; NEXWAVE

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

Patient Problem No Information (3190)

Event Date 06/05/2014

Event Type  malfunction  

Event Description

Unit gets hot after 2 minutes and shuts off.Had patient try battery, the unit will not work with battery that was sent.Unit comes on with adapter but gets hot and shuts off.

Manufacturer Narrative

Reporting due to fda findings during audit in 1/2015.Investigation and results: unit turned on, did not pass final testing.While in testing the unit was only ramped up to 6ma (ch.1/ch.2) and the current draw had already spiked up past the required current draw, which is 500ma at 50ma (ch.1/ch.2).Also unit does get really hot around the ac adaptor connection area.There are 2 common causes to this; first there could be bad components like q28 and q29.If these two are bad then it can cause it to have a high current draw with the high voltage to the transformer.Secondly, if the diodes near the jack are bad, it can send high voltage to the wrong parts and cause it to heat up.

• 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: 4574803
• MDR Text Key: 20728863
• Report Number: 1723686-2015-00002
• 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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2012
• 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