MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX; ELECTRICAL STIMULATOR

Model Number NEXWAVE

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2013

Event Type  malfunction  

Event Description

Unit got hot and started to smell like sulpher and burning smell.Then the unit shut off and doesn't turn on at all.

Manufacturer Narrative

Zynex: no unusual indications from exterior inspection.Internal inspection reveals that f1 shows signs of discoloration.F1, q27 and q28 bad.Any components that aren't functioning properly would give off a burning smell.Complaint confirmed.No harm to patient.

• Brand Name: ZYNEX
• Type of Device: ELECTRICAL STIMULATOR
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO 80120
• Manufacturer Contact: 9990 park meadows drive; lone tree, CO 80124 ; 3037034906
• MDR Report Key: 4617676
• MDR Text Key: 17998547
• Report Number: 1723686-2015-00014
• 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: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NEXWAVE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2012
• 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