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

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

Patient Problem Burn(s) (1757)

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Unit tested at user's facility and found to be within zynex manufacturings specifications.Investigation: unit, lead wires, and battery adapter all tested accordingly to spec with no issues.Conclusion: could not duplicate customer's complaint.Unit is working properly and no problem found.

Event Description

Patient reported a burn and sought medical attention.The clinic contacted us about the incident.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO
• Manufacturer Contact: 9990 park meadows drive; lone tree, CO 80120 ; 8004956670
• MDR Report Key: 5147824
• MDR Text Key: 28314921
• Report Number: 1723686-2015-00015
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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: 09/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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