BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARTON MEDICAL PORTABLE TROLLEY

    MDR report key: 3143194 · Received May 30, 2013

    Report

    Report Number
    2183887-2013-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BARTON MEDICAL
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RE-SELLER VISITED THE FACILITY TO INSPECT THE BOLT WHICH SECURED THE D-RING TO THE TROLLEY AND FOUND THE BOLT APPEARED TO BE FUNCTIONAL HOWEVER THE ASSEMBLY HAD NOT BEEN DRILLED TO RECEIVE A SAFETY ROLL PIN WHICH WOULD PREVENT THE D-RING FROM COMING UNSCREWED. RE-SELLER CONTACTED THE MANUFACTURER, BARTON MEDICAL, WHO RESPONDED WITH A QUALITY ALERT TO BE DISTRIBUTED TO ALL CUSTOMERS OWNING THE PRODUCT. RE-SELLER CONTACTED ALL CUSTOMERS REGARDING THE ALERT.

    Description of Event or Problem · 1

    DURING A PATIENT TRANSFER WITH A CEILING LIFT, THE PORTABLE MOTOR FELL FROM THE CEILING ONTO THE PATIENT AND NURSE. THE D-RING FROM THE CEILING LIFT TROLLEY CAME UNSCREWED CAUSING THE MOTOR TO FALL. THE PRODUCT WAS MANUFACTURED BY BARTON MEDICAL. THE PATIENT WAS OVER A SURFACE AT THE TIME AND REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238832 BARTON MEDICAL PORTABLE TROLLEY CEILING LIFT PORTABLE TROLLEY FNG BARTON MEDICAL RT-300-10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK