BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET RHEOLYTIC

    MDR report key: 2050964 · Received April 1, 2011

    Report

    Report Number
    2050964
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDRAD
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    DURING A TRAINING ON THE NEW ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM ALTRA CONSOLE, THE MACHINE STARTED TO BURN AND MALFUNCTIONED. THERE WERE NO PATIENTS INVOLVED AND NO STAFF WERE HARMED. THIS WAS A STAFF TRAINING ON THE USE OF THIS NEW DEVICE. THE VENDOR STOPPED THE TRAINING AND TOOK THE MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET RHEOLYTIC THROMBECTOMY REMOVAL SYSTEM DXE MEDRAD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *