BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPOWERCT AND EMPOWERCTA CEILING COLUMN

    MDR report key: 557602 · Received December 2, 2004

    Report

    Report Number
    2411512-2004-00013
    Event Type
    Malfunction
    Date Received
    December 2, 2004
    Date of Event
    November 1, 2004
    Report Date
    November 1, 2004
    Manufacturer
    ALGONQUIN INDUSTRIES, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SERVICE CALL THAT THE INJECTOR FELL OFF OF THE CEILING MOUNTING BRACKET AND LANDED ON THE FLOOR. THE UNIT DID NOT HIT THE TECHNICIAN OR THE PT. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * EMPOWERCTA INJECTOR SYSTEM MFG BY E-Z-EM, INC.