BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMAX 1000K

    MDR report key: 339759 · Received June 28, 2001

    Report

    Report Number
    MW1022279
    Event Type
    Malfunction
    Date Received
    June 28, 2001
    Report Date
    June 28, 2001
    Manufacturer
    EXCEL TECH LTD
    Product Code
    IKN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RPTR WROTE TO MFR CONCERNING THE FAILURE OF CO'S PRODUCT, EQUIPMENT#1 TO WORK PROPERLY. RPTR DESCRIBED THE DEFECT, THE HISTORY OF ATTEMPTS TO HAVE CO CORRECT THE DEFECT, AND THE FAILURE OF CO TO REMEDY THE SITUATION. MOREOVER, RPTR DESCRIBED THE THREAT TO PT HEALTH AND WELL-BEING POSED BY THE EQUIPMENT. ALTHOUGH RPTR HAS RECEIVED NO RESPONSE FROM CO, CO SENT A TECH TO INSPECT THE EQUIPMENT AGAIN. THE TECH NOTED THAT THE EQUIPMENT WAS CONNECTED TO THE WALL OUTLET BY AN EXTENSION WHICH HAD A DEFECTIVE "ON-LIGHT" AND RECOMMENDED REPLACEMENT. USER FOLLOWED TECH'S RECOMMENDATION TO REPLACE THE EXTENSION AND DETERMINED THAT THE EXTENSION WAS NOT RESPONSIBLE FOR EQUIPMENT#1 DEFICIENCIES BECAUSE THE DEFICIENCIES CONTINUED. CO THEN DELIVERED EQUIPMENT#2, A USED UNIT MFG IN 9/99, WHICH BEARS A CERTIFICATION THAT IT MEETS US STANDARD 544, AND SHOWS SIGNS OF MODIFICATION TO THE WIRING. STAFF HAS ATTEMPTED TO USE EQUIPMENT#2 IN THE CLINICAL CARE OF PTS. IT IS UNACCEPTABLE BECAUSE: (I) IN NERVE TESTING, THERE IS A RANDOM INSERTION OF EXTRA LETTERS INTO TEXT GENERATED BY THE EQUIPMENT; AND (II) MORE IMPORTANT, IN EMG TESTING THERE ARE SPURIOUS ELECTRICAL SIGNALS (NOISE) WHICH MAKE INTERPRETATION OF THE EMG CLINICALLY IMPOSSIBLE. THE ELECTRIC LINE TO WHICH THE EQUIPMENT WAS CONNECTED WAS TESTED BY A LICENSED ELECTRICIAN AND IS FREE OF SPURIOUS SIGNALS. A HIGH QUALITY LINE FILTER BROUGHT NO IMPROVMENT. WHEN EQUIPMENT#2 WAS MOVED TO A LEAD-LINED ROOM WITH A FILTERED ELECTRICAL SYSTEM IT SHOWED THE SAME NOISE AND DEFECTIVE TRACING, INDICATING THAT EXTRINSIC RADIO FREQUENCY AND LINE NOISE IS NOT A FACTOR IN THE FAILURE OF EQUIPMENT#2 TO PERFORM IN A MANNER CONSISTENT WITH ITS INTENDED PURPOSE AND SAFE FOR PTS. USER REASONABLY CONCLUDES THAT THE EQUIPMENT#1 AND EQUIPMENT#2 FAIL BECAUSE OF AN INHERENT DESIGN OR MFG FLAW AND ARE NOT SUITABLE FOR USE ON HUMAN SUBJECTS. USER QUESTIONS WHETHER CO'S CERTIFICATION ON THE EQUIPMENT THAT IT MEANS US STANDARD 544 IS ACCURATE AND TRUTHFUL. USER DEMANDS THAT CO IMMEDIATELY REPLACE THE DEFECTIVE EQUIPMENT WITH EQUIPMENT WHICH CONTINUOUSLY MEETS THE STANDARDS AND SPECIFICATIONS PUBLISHED FOR THE EQUIPMENT. IN ADDITION, CO IS TO BEAR THE COST OF ALL TESTING AND EXPENSES RELATED TO DEFECTIVE EQUIPMENT.

    Description of Event or Problem · 1

    EMG IS UNREADABLE CONFIRMED BY ENGINEERING AND MACHINE LOSES DATA AND THIS RESULTS IN ADD'L PAIN AND SUFFERING AS PTS HAVE TO HAVE PROCEDURE REPEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29418 NEUROMAX 1000K EMG IKN EXCEL TECH LTD * *
    29419 NEUROMAX 1000 * --- * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other