BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTE

    MDR report key: 16552365 · Received March 16, 2023

    Report

    Report Number
    3002250546-2023-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 16, 2023
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    K183123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FHC IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY FHC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. FHC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, FHC, OR ITS EMPLOYEES THAT THE DEVICE, FHC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. FHC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON THE MORNING OF (B)(6)2023, AN ADVERSE EVENT OCCURRED WITH THE GUIDELINE 5 (GL5). THE GL5'S UE INTERFACE C0219: SN(B)(4) FAILED THE SELF-TEST DURING POWER ON INITIALIZATION DUE TO A LOSS OF CONNECTIVITY WHICH OCCURRED DURING THE SELF-TEST. THE MEDICAL STAFF AT THE FACILITY CLICKED THROUGH THE FAILED SELF-TEST POP-UP DIALOG WARNING. A SINGLE MTD ELECTRODE WAS USED ON THE CENTER TRACK FOR THE CASE. MACRO-STIMULATION WAS PERFORMED. THE PATIENT HAD A SUDDEN MUSCLE CONTRACTION OF THE RIGHT FACE PULLING AND THE RIGHT ARM ELEVATING AND POSTURING (FINGERS AND WRIST FLEXED) THAT WAS PAINFUL. STIMULATION WAS IMMEDIATELY DISCONTINUED. STIMULATION CURRENT WAS ADJUSTED TO 0.1MA AND BRIEFLY REAPPLIED. PATIENT'S REACTION WAS SIMILAR TO THE PREVIOUS RESULT. THE STIMULATION MODE WAS CHANGED WITHIN THE STIMULATION DIALOG FROM CONSTANT CURRENT TO CONSTANT VOLTAGE WHICH ELICITED A THIRD PATIENT REACTION. STIMULATION WAS DISCONTINUED. ELECTRODE AND PATIENT LEAD WERE REPLACED FOR THE SECOND SIDE. OUT OF CAUTION NO STIMULATION WAS PERFORMED ON THE SECOND SIDE. THE CASE WAS COMPLETED WITHOUT PROBLEMS FHC,INC. HAS BEEN UNABLE TO RECREATE THE ISSUES DESCRIBED ON IN-STOCK UNITS, A REVIEW OF THE CUSTOMER UNIT WILL BE CONDUCTED UPON RETURN TO OUR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904759 MICROTARGETING¿ GUIDELINE 4000¿ 5.0 SYSTE GUIDELINE 5 GZL FHC, INC. GUIDELINE 4000 5.0 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other