BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMFORT

    MDR report key: 3230047 · Received July 11, 2013

    Report

    Report Number
    1041130-2013-00002
    Event Type
    Other
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    M.C. HEALTHCARE PRODUCTS A DIVISION OF SPAN MEDICAL PRODUCTS CANADA INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DETERMINED THAT THE WRONG RAIL WAS BEING USED ON THIS BED. THEY PURCHASED THESE, AS AN IN-HOUSE RETROFIT, BACK IN 2007 TO GIVE THE BED A TALLER RAIL. THIS IS THE ONLY KNOWN EVENT OF THIS NATURE. THE RAIL THEY PURCHASED WAS FROM A LEGACY BED AND NOT THIS MODEL. NEW RAILS WERE PURCHASED TO REPLACE THOSE IN QUESTION. ALL LEGACY RAILS IN HOUSE WERE DISCARDED TO HELP ENSURE OTHER CUSTOMERS CANNOT ORDER THESE AS WELL.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE PATIENT WAS FOUND, DURING NIGHTLY ROUNDS, TRAPPED UNDER THE SIDE RAIL. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319990 COMFORT BED FNL M.C. HEALTHCARE PRODUCTS A DIVISION OF SPAN MEDICAL PRODUCTS CANADA INC RM501

    Patients

    Seq Age Sex Outcome Treatment
    1