BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELCARE BARIATRIC BED FRAME

    MDR report key: 3093939 · Received April 26, 2013

    Report

    Report Number
    1045510-2013-00010
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM DISPATCHED A FIELD SERVICE TECHNICIAN TO INSPECT AND REPAIR THE BEDFRAME. AFTER A VISUAL INSPECTION OF THE BED AND SIDERAIL, HE DETERMINED THAT THE PINS HOLDING THE SIDERAIL TO THE BEDFRAME HAD RELEASED AND ALLOWED THE SIDERAIL RELEASE. THE TECHNICIAN REPLACED THE RIGHT HEAD SIDERAIL WITH ANOTHER ONE TO REPAIR THE BEDFRAME. THE SIDERAIL INVOLVED IN THIS EVENT WILL BE RETURNED TO HILL-ROM FOR A ROOT CAUSE INVESTIGATION AND A FOLLOW UP REPORT WILL BE SUBMITTED ONCE DETERMINED BY HILL-ROM ENGINEERING.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A COMPLAINT ON ONE OF ITS EXCELCARE BARIATRIC BED FRAMES ALLEGING THE PATIENT HAD INJURED THEIR SHOULDER AFTER FALLING FROM THE BED. THE PATIENT INDICATED HE ATTEMPTED TO POSITION HIMSELF IN BED USING THE RIGHT HEAD SIDERAIL WHEN IT RELEASED AND HE FELL OUT OF BED ONTO HIS LEFT SHOULDER. THE PATIENT RECEIVED TREATMENT FOR A CLOSED REDUCTION OF THE LEFT SHOULDER AS A RESULT OF THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181860 EXCELCARE BARIATRIC BED FRAME AC POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. P610B

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention