ZYNEX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-02-11 for ZYNEX manufactured by Zynex Medical Inc.

Event Text Entries

[5559092] Unit is burning and patient is getting channel ele errors, he uses the tens unit on 25-30ma's.
Patient Sequence No: 1, Text Type: D, B5

[12952716] Reporting due to fda findings during audit in 1/2015. Investigation and results: unit arrived in ifc-lowhigh, 40 minutes. (b)(4). This unit draws excessive current; q26 and q3 are damaged due to overheating. Electrode wires and power supply are functioning properly.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1723686-2015-00006
• MDR Report Key: 4574816
• Report Source: 04
• Date Received: 2015-02-11
• Date of Report: 2015-02-05
• Date of Event: 2014-06-26
• Date Mfgr Received: 2014-06-26
• Device Manufacturer Date: 2011-04-13
• Date Added to Maude: 2015-03-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: 9990 PARK MEADOWS DR
• Manufacturer City: LONE TREE CO 80124
• Manufacturer Country: US
• Manufacturer Postal: 80124
• Manufacturer Phone: 8004956670
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ZYNEX
• Generic Name: TRUWAVE PLUS
• Product Code: IPF
• Date Received: 2015-02-11
• Returned To Mfg: 2014-07-11
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZYNEX MEDICAL INC
• Manufacturer Address: LONE TREE CO 80124 US 80124

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-02-11