BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOMAPPING SYSTEM

    MDR report key: 1022083 · Received March 27, 2008

    Report

    Report Number
    MW5006071
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 27, 2008
    Manufacturer
    BIOSCIENCE WEBSTER
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE MAKING ODD BEEPING SOUND NOISES ON SAFETY CHECK BEFORE PATIENT WAS PUT ON TABLE FOR PROCEDURE. NOTIFIED MANUFACTURER AND WORKED WITH TECH SUPPORT TO TROUBLE SHOOT. DETERMINED SYSTEM COULD NOT BE FIXED WITHOUT A NEW PART. PATIENT IN VENTRICULAR TACHYCARDIA STORM AND NEEDED EMERGENT ELECTROPHYSIOLOGY ABLATION. TRANSFERRED EMERGENTLY TO ANOTHER FACILITY FOR EP ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOMAPPING SYSTEM NONE HAW BIOSCIENCE WEBSTER FG-4700-00 VERSION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| S