BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMASTER

    MDR report key: 21019733 · Received December 26, 2024

    Report

    Report Number
    8030229-2024-04602
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 4, 2024
    Report Date
    February 13, 2025
    Manufacturer
    NIHON KOHDEN CORPORATION
    Product Code
    GWF
    UDI-DI
    00841983103612
    PMA / PMN Number
    K142624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A 60 HERTZ ARTIFACT WHILE PERFORMING EMG SURGERY. THE CUSTOMER RESEATED THE AMP TO RESOLVE THE ISSUE. TECHNICAL SUPPORT (TS) INFORMED THE CUSTOMER TO USE THE GRD CABLE WITH ALLIGATOR CLIP. THERE WAS NO PATIENT INJURY REPORTED. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A 60 HERTZ ARTIFACT WHILE PERFORMING EMG SURGERY. THE CUSTOMER RESEATED THE AMP TO RESOLVE THE ISSUE. TECHNICAL SUPPORT (TS) INFORMED THE CUSTOMER TO USE THE GRD CABLE WITH ALLIGATOR CLIP. THERE WAS NO PATIENT INJURY REPORTED. INVESTIGATION SUMMARY: BASED ON THE AVAILABLE INFORMATION, WE CONFIRMED THE REPORTED ISSUE; HOWEVER, DUE TO LIMITED INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT DETERMINED. THE FOLLOWING FIELD(S) CONTAIN NO INFORMATION (NI), AS ATTEMPTS TO OBTAIN INFORMATION WERE MADE, BUT NOT PROVIDED: D10 ATTEMPT # 1: 12/12/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 2: 12/16/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ATTEMPT # 3: 12/18/2024 EMAILED THE CUSTOMER VIA MICROSOFT OUTLOOK FOR ALL INFORMATION IN THE NI LIST ABOVE: NO REPLY WAS RECEIVED. ADDITIONAL INFORMATION: B4 DATE OF THIS REPORT G3 DATE RECEIVED BY MANUFACTURER G6 TYPE OF REPORT H2 IF FOLLOW UP, WHAT TYPE? H11 ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A 60 HERTZ ARTIFACT WHILE PERFORMING EMG SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A 60 HERTZ ARTIFACT WHILE PERFORMING EMG SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732857 NEUROMASTER NEURAL FUNCTION MEASURING SYSTEM GWF NIHON KOHDEN CORPORATION MEE-2000A-DT NA 00841983103612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NI.| NI.