BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER AIMING DEVICE

    MDR report key: 14730 · Received July 18, 1994

    Report

    Report Number
    MW1002850
    Event Type
    Malfunction
    Date Received
    July 18, 1994
    Date of Event
    June 29, 1994
    Report Date
    July 5, 1994
    Manufacturer
    OEC-DIASONICS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DEVICE HAS 3 POINTS OF ATTACHMENT TO THE IMAGE INTENSIFIER. THREE STAINLESS STEEL SPRING CLIPS ARE DESIGNED TO HOLD THE DEVICE IN PLACE. THE CONTACT SURFACE OF THE CLIPS IS NOT ADEQUATE TO HOLD SHOULD ONE OF THE 3 CLIPS LOSE TENSION. THE DEVICE HAD FALLEN AND STRUCK A PT DURING A PROCEDURE, FOR NO APPARENT REASON. THERE WAS NO CONTACT WITH THE DEVICE OR CLIPS AT THE TIME OF THE EVENT. A BIOMEDICAL ENGINEER, THE X-RAY TECHNOLOGIST WHO WAS OPERATING THE EQUIPMENT, AND THE MGR OF RADIOLOGY EXAMINED BOTH DEVICES THAT ARE ON PREMISES AND THEIR ABILITY TO HOLD, AND FOUND THAT WITH EVEN SLIGHT MOVEMENT OF ONE CLIP, THE DEVICES WOULD FALL. THERE HAS BEEN NO PREVIOUS OCCURRENCE OF THIS PROBLEM REPORTED AT RPTR'S FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER AIMING DEVICE MOBILE MEDICAL RADIOGRAPHIC/FLUOROSCOPIC SYSTEM JAA OEC-DIASONICS, INC. 00-874765-02

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other