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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNEX MEDICAL, INC. ZYNEX; ELECTRICAL STIMULATOR
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ZYNEX MEDICAL, INC. ZYNEX; ELECTRICAL STIMULATOR Back to Search Results
Model Number NEXWAVE
Device Problem Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2013
Event Type  malfunction  
Event Description
Channel 1 error occurs 10-15 minutes into treatment/burned plastic smell.Had pt test lw switched lw then run unit again.Channel 1 error occurred after lw were switched.Pt indicates that she can smell burned plastic.No harm to pt.
 
Manufacturer Narrative
Zynex: unit was tested with no problem found and passed the final test.Tested for duration with no burned plastic smell or errors of any kind.There is no evidence internally or externally suggesting unit ever got hot or had any burning plastic smell.
 
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Brand Name
ZYNEX
Type of Device
ELECTRICAL STIMULATOR
Manufacturer (Section D)
ZYNEX MEDICAL, INC.
lone tree CO 80124
Manufacturer Contact
9990 park meadows drive
lone tree, CO 80124
3037034906
MDR Report Key4613354
MDR Text Key5702202
Report Number1723686-2015-00010
Device Sequence Number1
Product Code IPF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 03/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberNEXWAVE
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/13/2013
Is the Reporter a Health Professional? No
Date Manufacturer Received11/13/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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