MAUDE Adverse Event Report: ZYNEX MEDICAL ZYNEX; NEXWAVE

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

Patient Problem No Information (3190)

Event Date 02/27/2013

Event Type  malfunction  

Event Description

The unit was smoking.

Manufacturer Narrative

Conclusion: the q26, 27, 28, 29 components were the cause of the failure.

• 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 ; 3037034906
• MDR Report Key: 4445134
• MDR Text Key: 5314266
• Report Number: 1723686-2014-00005
• 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: Unknown
• Reporter Occupation: Not Applicable
• 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?: Yes
• Date Returned to Manufacturer: 03/21/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other