BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT BED

    MDR report key: 1891471 · Received October 27, 2010

    Report

    Report Number
    1891471
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    HILL-ROM
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BRAKES ON HOSPITAL BED WERE NOT FUNCTIONING PROPERLY AND WERE REPORTED TO ENGINEERING OFFICE. WHILE WAITING FOR ENGINEERING TO EVALUATE BED, WHEN PATIENT ATTEMPTED TO SIT UP, WHEEL OF BED BROKE CAUSING BED TO TIP, INJURING PATIENT'S DAUGHTER WHO TRIED TO SUPPORT THE BED, THIS WAS A MINOR INJURY WITHOUT ANY REDNESS OR SKIN BREAK. BED WAS TAKEN OUT OF SERVICE AND REPLACED.====================== MANUFACTURER RESPONSE FOR PATIENT BED, PATIENT BED======================HILL ROM REPRESENTATIVE IS SCHEDULED TO VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT BED PATIENT BED FNL HILL-ROM 1165 ADVANCE W/ ZONE AIR SCALE *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR