BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEE HIVE

    MDR report key: 25773 · Received January 19, 1995

    Report

    Report Number
    25773
    Event Type
    Other
    Date Received
    January 19, 1995
    Date of Event
    July 27, 1994
    Report Date
    August 1, 1994
    Manufacturer
    TELEFACTOR CORP.
    Product Code
    GYA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED A BURNING SENSATION WHEN LEADS OF AN EEG MACHINE WERE PLUGGED IN. THE PROCEDURE WAS STOPPED AND THE INCIDENT INVESTIGATED.THE EQUIPMENT WAS TESTED BY BIOMEDICAL ENGINEERS AND FOUND TO BE DEFECTIVE. EQUIPMENT WAS THEN RETURNED TO MANUFACTURER FOR ADDITIONAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEE HIVE DIGITAL TELEMETRY MULTIPLEXER GYA TELEFACTOR CORP. DTM 1064

    Patients

    Seq Age Sex Outcome Treatment
    1 26 * Other