BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE BED

    MDR report key: 3071180 · Received April 9, 2013

    Report

    Report Number
    1824206-2013-02051
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INVESTIGATED THE SIDE RAILS AND FOUND THE LEFT HEAD SIDE RAIL LATCHED AND LOCKED AND THE LATCH WAS CLEAR AND CLEAN. THE RELEASE HANDLE WORKED PROPERLY WITH NO STICKING AND THE SIDE RAIL PIVOTED SMOOTH AND WOULD NOT STAY UP WITHOUT FULLY LATCHING. THE ACCOUNT STATED THAT THE PATIENT STATED THAT HE WAS PULLING ON THE SIDE RAIL TO ADJUST HIS POSITION AND THEN TURNED AND LEANED OUT ON THE LEFT SIDE RAIL AND THE SIDE RAIL DID NOT HOLD. THE PATIENT ALLEGED THAT THIS CAUSED HIM TO FALL OUT OF THE BED AND ONTO HIS HANDS AND KNEES BUT DID NOT RECEIVE AN INJURY. THE TECHNICIAN INSPECTED THE BED EXIT ALSO AND THE BED FUNCTIONED AS DESIGNED, NO ISSUE WITH THE SIDE RAILS OR THE BED EXIT.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THAT A PATIENT WAS ATTEMPTING TO EXIT THE BED AND WAS USING THE LEFT HEAD SIDE RAIL FOR SUPPORT. THE ACCOUNT ALLEGED THE LEFT HEAD SIDE RAIL WAS IN THE UPRIGHT POSITION AND THE LEFT INTERMEDIATE SIDE RAIL WAS IN THE LOWERED POSITION WHEN THE INCIDENT OCCURRED. THE ACCOUNT ALLEGED THE LEFT HEAD SIDE RAIL LOWERED UNEXPECTEDLY AND THE PATIENT FELL FROM THE BED TO THE FLOOR ONTO THEIR KNEES. NO MEDICAL ATTENTION REQUIRED, THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144521 TOTAL CARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1900

    Patients

    Seq Age Sex Outcome Treatment
    1