BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMPOWERCT CEILING COLUMN

    MDR report key: 644853 · Received November 3, 2005

    Report

    Report Number
    2411512-2005-00007
    Event Type
    Other
    Date Received
    November 3, 2005
    Date of Event
    October 3, 2005
    Report Date
    October 3, 2005
    Manufacturer
    ALGONQUIN INDUSTRIES, INC
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE E-Z-EM FIELD SERVICE TECHNICIAN RECEIVED A CALL FROM THE USER FACILITY STATING THE COMPLETE CEILING MOUNT SYSTEM FELL. PER THE FACILITY ENGINEER, THE ANCHORS INSTALLED TO SECURE THECEILING COLUMN'S PLATE TO THE CEILING FAILED. FACILITY ENGINEER REQUESTED AN INSTALLATION MANUAL AND INSTALLED THE INJECTOR ON THEIR ORIGINAL FLOOR STAND. THE INJECTOR WAS TESTED AND IS WORKING PROPERLY. NO ONE WAS INJURED AS A RESULT OF THIS EVENT, ALTHOUGH THE TECHNICIAN INDICATED SHE STRAINED HER MUSCLES HOLDING THE SYSTEM UP SO IT WOULD NOT FALL ON THE PATIENT. NO SUBSEQUENT MEDICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPOWERCT CEILING COLUMN CEILING MOUNT ACCESSORY JAK ALGONQUIN INDUSTRIES, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other