BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADWELL EEG SYSTEM

    MDR report key: 6857529 · Received September 12, 2017

    Report

    Report Number
    MW5072079
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    August 25, 2017
    Report Date
    August 30, 2017
    Manufacturer
    CADWELL INDUSTRIES, INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WE RECEIVED A BRAND NEW DEVICE FROM (B)(4). THE UNIT WAS CHARGING BEFORE BEING SENT OUT WITH A PATIENT. THE UNIT MADE A LOUD NOISE, SMOKE WAS SMELLED AND THE UNIT WAS HOT TO TOUCH. ONCE UNPLUGGED AND INVESTIGATED, WE FOUND THE BATTERY PACK FOR THE CAMERA EXPLODED AND BURNED UP. THE UNIT WAS NEVER PUT INTO SERVICE. AFTER CONTACTING (B)(4) THEY SAID THIS IS THE THIRD TIME THIS HAS HAPPENED. WE DO NOT FEEL SAFE SENDING THESE SYSTEMS HOME WITH PATIENTS, OR EVEN USING THEM IN THE HOSPITAL. THE SYSTEM HAS BEEN SENT BACK TO (B)(4) ON (B)(6) 2017 FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637158 CADWELL EEG SYSTEM CADWELL EEG SYSTEM GWF CADWELL INDUSTRIES, INC. Q-VIDEO MOBILE 2

    Patients

    Seq Age Sex Outcome Treatment
    1