BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 1941358 · Received December 21, 2010

    Report

    Report Number
    1723686-2010-00007
    Event Type
    Other
    Date Received
    December 21, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO VISUAL DEFECTS OBSERVED. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(4) 2010 WITH NO ISSUES. MODE=TENS, SWEEP:, TIMER: 50 MIN. UNIT TESTED BY (B)(4), MANUFACTURING TECHNICIAN ON (B)(4) 2010. THE DEVICE SELECTED IS 'TENS' AFTER TURNING ON THE UNIT. THE "UP" ARROW BUTTON FOR CHANNEL 2 WOULD STICK AFTER TRYING TO RAMP UP CHANNEL 2. HE REMOVED BUTTON OVERLAY MATERIAL THAT HAD BEEN OBSTRUCTING THE RANGE OF MOTION FOR THE BUTTON. THIS IS THE FIRST INCIDENT OF THIS TYPE FOR THIS PRODUCT. THE UNIT WAS THEN TESTED PER THE FINAL TEST PROCEDURE AND PASSED ALL TESTS. UNIT RELEASED TO THE SERVICE AREA FOR PROCESSING INTO THE USED INVENTORY. CONCLUSION: ASSEMBLY ERROR, THE EXCESS MATERIAL IN THE BUTTON HOLE WAS THE CAUSE OF THE FAILURE BECAUSE, THE OVERLAY WAS SLIGHTLY OFF CENTER. CORRECTIVE ACTION: THE ASSEMBLERS WERE NOTIFIED TO CHECK FOR THIS OVERLAY MATERIAL OBSTRUCTING ANY BUTTON MOVEMENT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    PATIENT REPORTED SEVERE PAIN DUE TO THE UP STIM BUTTON WAS STUCK, AND A "BURN" OCCURRED ON HER SKIN UNDER THE ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX TENS ELECTRICAL STIMULATOR IPF ZYNEX MEDICAL, INC. TRUWAVE PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other