BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROSCOPE UNIVERSAL CORD

    MDR report key: 258501 · Received January 10, 2000

    Report

    Report Number
    1722040-2000-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2000
    Date of Event
    December 3, 1999
    Report Date
    January 9, 2000
    Manufacturer
    ELECTROSCOPE, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOSP'S VOLUNTARY REPORT 06-0031-1999-0024 STATED "CORD WAS ATTACHED TO THE SCOPE (INSTRUMENT) AND THE CORD SPARKED, SMOKED AND BURNED HOLE IN CORD. THE NURSING STAFF WERE SURE THE CORD WAS ATTACHED PROPERLY. NO INJURY TO PT." HOSP RISK MGR EXPRESSED BY PHONE 01/06/2000 CONCERN ABOUT RISK OF SPARK FROM CORD IGNITING ADJACENT MATERIAL IF PROBLEM WERE TO RECUR. PRODUCT OBTAINED BY ELECTROSCOPE INC FOR EVALUATION ON 01/07/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROSCOPE UNIVERSAL CORD ACTIVE ELECTRODE MONITORING SYSTEM COMPONENT GEI ELECTROSCOPE, INC. ES4007 EC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other