BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICARE COLUMN

    MDR report key: 1506623 · Received October 8, 2009

    Report

    Report Number
    1836145-2009-00003
    Event Type
    Malfunction
    Date Received
    October 8, 2009
    Date of Event
    September 8, 2009
    Report Date
    September 9, 2009
    Manufacturer
    HILL-ROM ARCHITECURAL PRODUCTS / HILL-ROM CO. INC
    Product Code
    IYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INSPECTED THE COLUMN AND COULD NOT DUPLICATE THE ALLEGED MALFUNCTION. THE TECHNICIAN DID FIND SMALL AIR LEAKS BETWEEN THE CONTROL HOSES AND PRESS LOCK FITTINGS. THE HOSES WERE RE-FITTED TO THE PRESS LOCK FITTINGS TO STOP THE LEAKS. THE ACCOUNT DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EVENT.

    Description of Event or Problem · 1

    ALLEGED THE RETRACTABLE CEILING COLUMN DRIFTS DOWN UNEXPECTEDLY. ON (B)(6), AN OR EMPLOYEE WAS HIT ON THE HEAD WHEN THE CEILING COLUMN DRIFTED DOWN. THE EMPLOYEE HAD A HEADACHE, WENT TO ER, IS REPORTED TO HAVE A CONCUSSION AND WAS SENT HOME FOR THE DAY. THE EMPLOYEE IS WORKING BUT STILL CLAIMS TO HAVE AN ONGOING HEADACHE. THE FACILITY INDICATED THE DRIFT HAS BEEN HAPPENING FOR SOMETIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARE COLUMN CEILING COLUMN IYB HILL-ROM ARCHITECURAL PRODUCTS / HILL-ROM CO. INC 680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK