BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 668099 · Received December 13, 2005

    Report

    Report Number
    668099
    Event Type
    Malfunction
    Date Received
    December 13, 2005
    Date of Event
    August 19, 2005
    Report Date
    December 13, 2005
    Manufacturer
    TI-BA ENTERPRISES, INC. (MAVIG GMBH)
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS BEING DRAPED FOR THE PROCEDURE, THE X-RAY ARM BROKE AND FELL OFF FROM THE CEILING SUSPENSION SYSTEM STRIKING THE CATH LAB TECH ON THE SHOULDER. THE TECH HAD LIFTED THE SHIELD PART OF THE X-RAY ARM UP WHEN THE UPPER PART OF THE ARM BROKE FALLING TO THE GROUND. THE PATIENT WAS NOT STRUCK BY THE ARM NOR WERE THEY INJURED IN ANY WAY. THIS WAS THE FOURTH OCCURRENCE OF THIS TYPE EXPERIENCED BY FACILITY. MAVIGG REPLACED ALL CEILING SUSPENSION SYSTEMS IN THIS FACILITY IN SEPTEMBER, 2005 WITH A STEEL VERSION OF THE PRODUCT AND THERE HAVE BEEN NO ADDITIONAL INCIDENTS SINCE THE EQUIPMENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CEILING SUSPENSION SYSTEM IYB TI-BA ENTERPRISES, INC. (MAVIG GMBH) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *
    2