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

Device Problems Circuit Failure (1089); Temperature Problem (3022)

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

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

Nexwave, (b)(4), evaluated on (b)(4) 2015.No problem found on the actual device.Ran unit in ifc mode for 10 minutes w/out any abnormal heating issue.Ran the unit for an additional 15 minutes, which the ifc was hooked up to the lbg, again, no issue.Lbg; supply item, was evaluated as well, because the patient claimed that the electrodes wouldn't stay fastened, regardless of the lbg used.The evaluation revealed there was no problem found.Engineering technician suggests that there was poor attachment of electrodes causing poor adherence.Patient error.

Event Description

Patient reports unit was getting hot.Electrodes wouldn't stay fastened regardless of the lbg used.

• Brand Name: ZYNEX
• Type of Device: NEXWAVE
• Manufacturer (Section D): ZYNEX MEDICAL, INC.; lone tree CO 80124
• Manufacturer Contact: 9900 park meadows drive; lone tree, CO 80124 ; 8004956670
• MDR Report Key: 5153137
• MDR Text Key: 28500822
• Report Number: 1723686-2015-00016
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• 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: 09/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• 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