BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENEX

    MDR report key: 692325 · Received March 8, 2006

    Report

    Report Number
    692325
    Event Type
    Malfunction
    Date Received
    March 8, 2006
    Date of Event
    February 27, 2006
    Report Date
    March 8, 2006
    Manufacturer
    KENEX (ELECTRO-MEDICAL) LTD.
    Product Code
    EAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN WAS LIGHTLY TUGGING ON CEILING-MOUNTED LEADED GLASS SCREEN IN ORDER TO MOVE IT TO A DESIRABLE WORKING LOCATION. SECONDS LATER IT CAME CRASHING DOWN NEXT TO HER. THE CEILING MOUNTED STANCHION HAD FATIGUED WHERE IT SUPPORTS THE VERTICAL ARM OF THE SCREEN/ARM SYSTEM. SYSTEM WAS INSTALLED AND SUPPLIED BY SEIMENS, BUT THEY ARE NOT THE MANUFACTURER. PM WAS DONE ON 2/23/06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENEX SUSPENSION SYSTEM, XRAY SHIELD EAK KENEX (ELECTRO-MEDICAL) LTD. 350 *
    2 SIEMENS MULTISTAR XRAY SYSTEM, CARDIAC CATH IZI SIEMENS MEDICAL SOLUTIONS USA, INC. G5419 *
    3 SIEMENS MULTISTAR XRAY SYSTEM, CARDIAC CATH IZI SIEMENS MEDICAL SOLUTIONS USA, INC. G2182 *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR