BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 1403891 · Received June 16, 2009

    Report

    Report Number
    1723686-2009-00002
    Event Type
    Other
    Date Received
    June 16, 2009
    Date of Event
    March 31, 2008
    Report Date
    June 16, 2009
    Manufacturer
    ZYNEX MEDICAL
    Product Code
    LIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED AT THE RECOMMENDATION OF (B)(6) , FDA INVESTIGATOR AFTER AN INSPECTION OF ZYNEX MEDICAL ON 6/3/09-6/10/09. CONCLUSION: 6/9/08. PCB INSPECTED, TESTED AND REWORKED BY (B)(4) . REMOVED Q31. PADS FOR PINS 1 AND 2 HAD DISINTEGRATED AND COULD NOT BE SALVAGED. SOLDERED IN NEW (B)(4) (ONLY PIN 3). REMOVED Q30, (B)(4) AND REPLACED IT WITH (B)(4) . SOLDERED IN SHORT, 30 AWG JUMPERS BETWEEN Q31-2 AND Q30-2, AND BETWEEN Q31-1 AND Q30-3. BURNED IN FOR 60 MINUTES USING 12 VDC SUPPLY CONNECTED TO AC ADAPTER JACK. STARTING CURRENT DRAW WAS 400 MA. OUTPUT WAS 42 V PEAK. ENDING CURRENT DRAW WAS 36- MA. TESTED ELECTRODE ALARM AT 4, 20 AND 50 MA. WOULD ONLY WORK AT 4 MA. IMPLEMENTED BALANCE OF ECO 1023. NOTE: (B)(4) SWAP OUT WITH (B)(4) WAS PART OF ECO 1023. QUICK TEST OF CURRENT DRAW AND ELECTRODE ALARM CAPABILITY DID NOT REVEAL ANY SIGNIFICANT CHANGE. REASSEMBLED UNIT. UNIT RELEASED TO THE REPAIR AREA FOR PROCESSING INTO THE USED INVENTORY. CORRECTIVE ACTION: UNIT WILL BE UPDATED PER ECO 1023. NEW REV OF BOARD THAT IS IN THE TEST AND PROTOTYPE PHASE, WILL ELIMINATE THIS PROBLEM FROM OCCURRING.

    Description of Event or Problem · 1

    PATIENT STATED THAT WHEN THE DEVICE WAS TURNED ON, IT FELT LIKE IT WAS BURNING AND SHOCKING HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX INTERFERENTIAL ELECTRICAL STIMULATOR LIH ZYNEX MEDICAL IF 8000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other