BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESWL GAIT ATTACHMENT EQUIPMENT

    MDR report key: 1982444 · Received January 26, 2011

    Report

    Report Number
    1982444
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 24, 2011
    Manufacturer
    UNITED THERAPIES
    Product Code
    NCV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LITHOTRIPSY PROCEDURE, THE SAFETY FEATURE ON THE GAIT ATTACHMENT FOR ESWL EQUIPMENT DID NOT OPERATE CORRECTLY. THE EQUIPMENT WAS BEING OPERATED BY THE COMPANY REP. THIS WAS DISCUSSED WITH SURGEON AND ANESTHESIOLOGIST AND THE EQUIPMENT WAS USED WITHOUT THE GAIT ATTACHMENT. COMPANY REP TOOK THE EQUIPMENT FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESWL GAIT ATTACHMENT EQUIPMENT NONE NCV UNITED THERAPIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other