BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROPTICS

    MDR report key: 11677660 · Received April 16, 2021

    Report

    Report Number
    11677660
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    April 2, 2021
    Report Date
    April 6, 2021
    Manufacturer
    NEUROPTICS, INC.
    Product Code
    HLG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PUPILLOMETER DOES NOT HOLD A CHARGE AT ALL. MULTIPLE PATIENTS HAVE AN ORDER TO CHECK PUPILS WITH THIS DEVICE AND MY NURSES ARE UNABLE TO DO SO. THE COMPANY WAS CONTACTED REGARDING THIS FAULTY PRODUCT AND WE RECEIVED NO RESPONSE. THE NICU IS ALSO EXPERIENCING THE SAME ISSUE. THE DEVICE THAT WE HAD BEEN USING SINCE THE ISSUE WAS DISCOVERED ACTUALLY BELONGS TO THE NICU. BIOMED HAS ALSO BEEN CONTACTED. THE NEURO CRITICAL CARE TEAM WAS NOTIFIED THIS MORNING BY THE CHARGE NURSE THAT WE WOULD NOT BE ABLE TO PROVIDE ANY PATIENT WITH A PUPILLOMETER READING AT THIS TIME UNTIL THIS PROBLEM IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574058 NEUROPTICS PUPILLOMETER, AC-POWERED HLG NEUROPTICS, INC. NPI-200 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1