BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLINK TWITCHVIEW TRAIN OF FOUR MONITOR

    MDR report key: 23684528 · Received December 1, 2025

    Report

    Report Number
    MW5179651
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 21, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BLINK DEVICE COMPANY
    Product Code
    KOI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I ATTEMPTED TO USE THE BLINK TWITCHVIEW TRAIN OF FOUR MONITOR TO MONITOR NEUROMUSCULAR BLOCKADE IN MY PATIENT. OF NOTE, SHE HAD ANASARCA. ALTHOUGH THE EMG ELECTRODES WERE PROPERLY POSITIONED AND THE DEVICE WAS PROPERLY EVOKING VIGOROUS MOVEMENTS OF THE THUMB, ONLY WEAK (PEAK ~1 MV) EMG SIGNALS WERE DETECTED AT 80MA. I ATTRIBUTED THIS PROBLEM TO EDEMA ALTERING THE CONDUCTIVE PROPERTIES OF THE TISSUES BETWEEN THE PATIENT'S MUSCLES AND SKIN. FOR THE REMAINDER OF THE OPERATION, I USED THE DEVICE AS A NERVE STIMULATOR ONLY, ASSESSING THE DEGREE OF NEUROMUSCULAR BLOCK BY VISUAL AND MANUAL OBSERVATION OF THE THUMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2854731 BLINK TWITCHVIEW TRAIN OF FOUR MONITOR STIMULATOR, NERVE, PERIPHERAL, ELECTRIC KOI BLINK DEVICE COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female