BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTROHYDRAULIC LITHOTRIPTOR

    MDR report key: 35705 · Received July 12, 1996

    Report

    Report Number
    35705
    Event Type
    Malfunction
    Date Received
    July 12, 1996
    Report Date
    June 30, 1996
    Manufacturer
    NORTHGATE TECHNOLOGY, INC.
    Product Code
    FFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTROHYDRALIC LITHOTRIPTOR WAS BEING USED IN OR. IT WAS NOTED THAT THE CABLES WERE IN THE WRONG PORT. AS THE RN WAS ABOUT TO REMOVE THE CABLES, SHE AND THE PT EXPERIENCED A SHOCK. LITHOTRIPTOR WAS REMOVED BY BIOMEDICAL ENGINEERING AND ALL THE TESTS PERFORMED AS PER MFR'S SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROHYDRAULIC LITHOTRIPTOR ELECTROHYDRAULIC LITHOTRIPTOR FFK NORTHGATE TECHNOLOGY, INC. SD-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *