BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOLOGIC

    MDR report key: 1022399 · Received March 12, 2008

    Report

    Report Number
    1022399
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 12, 2008
    Manufacturer
    BIO-LOGIC SYSTEMS CORPORATION
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT MALFUNCTIONED. EEG PROVIDED IMPROPER DATA TO TECHNICIAN DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOGIC EEG MACHINE GWQ BIO-LOGIC SYSTEMS CORPORATION CEEGRAPH NETLINK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR