MAUDE Adverse Event Report: ZYNEX MEDICAL ZYNEX; NEXWAVE

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

Patient Problem No Information (3190)

Event Date 11/21/2012

Event Type  malfunction  

Event Description

Patient states that the unit got hot and smelled like it was burning.

Manufacturer Narrative

Reporting due to a fda finding during an audit in 01/2014.No injury to the patient.Conclusion: the q28 and q29 components were the cause of the failure.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL; lone tree CO 80124
• Manufacturer Contact: 9990 park meadows dr.; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 4445138
• MDR Text Key: 5316969
• Report Number: 1723686-2014-00002
• 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: 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: 12/17/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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