BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XL BARIATRIC BED

    MDR report key: 4356333 · Received December 18, 2014

    Report

    Report Number
    1824206-2014-02840
    Event Type
    Injury
    Date Received
    December 18, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 20, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    OSI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN EXAMINED THE BED AT THE REQUEST OF THE ACCOUNT AND COULD NOT FIND ANY MALFUNCTIONS. HE CONFIRMED FROM THE NURSING STAFF THAT AT THE TIME OF THE FALL THE SIDE RAILS WERE DOWN. HE CONFIRMED THAT THE SIDE RAILS COULD BE RAISED AND LOCKED IN THE UPRIGHT POSITION. THERE WAS NO EVIDENCE OF ANY MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. THE SIDE RAILS WERE DOWN WHEN THE PATIENT FELL OUT OF BED. ALTHOUGH SIDE RAILS ARE NOT INTENDED AS A PATIENT RESTRAINT, THE USE OF THE SIDE RAILS IS INTENDED TO BE A REMINDER TO THE PATIENT OF THE UNIT'S EDGES.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT WAS ASLEEP IN THE BED AND AWOKE WHEN SHE FELT HER LEG SLIPPING OFF THE BED AND ONCE IT SLIPPED OFF, THE REST OF HER BODY FELL OFF AS WELL. THE ACCOUNT CONFIRMED THE SIDE RAILS OF THE BED WERE DOWN AT THE TIME OF THE INCIDENT AND THE PATIENT BROKE BOTH HER LEFT AND RIGHT FEMURS. THE PATIENT WAS TRANSPORTED TO THE UNIVERSITY OF KANSAS TO HAVE SURGERY TO ADDRESS THE INJURIES. THE BED WAS LOCATED IN 2102 2EWA AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831106 XL BARIATRIC BED BARIATRIC BED OSI HILL-ROM, INC. 610B

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other