BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HILL-ROM VERSACARE BED

    MDR report key: 2894683 · Received May 15, 2008

    Report

    Report Number
    2894683
    Event Type
    Injury
    Date Received
    May 15, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 13, 2008
    Manufacturer
    HILL-ROM
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT ADMITTED FOR FLUID OVERLOAD AND CHF. PT WITH HISTORY OF CHRONIC RENAL FAILURE, HEMODIALYSIS DEPENDENT, DIABETES AND A RIGHT BELOW THE KNEE AMPUTATION. ON (B)(6) 2008, THE PT WAS BEING CLEANED BY A NURSE. THE PT WAS ROLLED ON HER SIDE WITH HEAD AND FOOT SIDERAILS UP ON THE SIDE THE PT WAS FACING. WHEN PT SHIFTED TO HER SIDE, SHE LEANED AGAINST THE LOWER FOOT SIDERAIL, THE RAIL DISENGAGED AND THE PT TUMBLED TO THE FLOOR. PT RECEIVED SEVERE CONTUSIONS TO THE HEAD, HAND, AND KNEE. THE PT SUFFERED A SMALL SUBARACHNOID HEMORRHAGE. THE HEAD BLEED DID SEAL ITSELF OFF AND DID NOT REQUIRE SURGICAL INTERVENTION. THE PT STABILIZED AND WAS DISCHARGED TO A SKILL NURSING FACILITY ON (B)(6) 2008. THE PT LIVES ALONE AND DUE TO THE EXTENSIVE SOFT TISSUE DAMAGE TO THE LEFT HAND, THE PT IS NOT ABLE AT THIS TIME TO CARE FOR HERSELF. SHE WILL REMAIN AT THE SKILLED NURSING FACILITY UNTIL SHE IS ABLE TO RETURN HOME ALONE. UPON INSPECTION OF THE BED BY HILL-ROM, THE LATCHING DEVICE FAILED INSIDE THE SIDE-RAIL. THE DESIGN OF THE SIDERAIL ALLOWS MOISTURE/SUBSTANCES TO SEEP THROUGH THE SEAMS OF THE SIDERAIL, RESULTING IN BUILD UP OF MATERIAL ON THE SPRING AND LATCHING DEVICE. THERE IS NO WAY TO SEE THAT THE SPRING/LOCKING MECHANISM MAY BE COATED AND NOT FULLY ENGAGING UNLESS THE SIDERAIL IS DISMANTLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HILL-ROM VERSACARE BED VERSACARE BED FNL HILL-ROM 3200

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other