BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL CARE

    MDR report key: 2854935 · Received November 15, 2012

    Report

    Report Number
    2854935
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 15, 2012
    Manufacturer
    HILL ROM
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO NURSES WERE PROVIDING CARE TO A PATIENT IN CCU. PT WAS TOTAL CARE (E.G.: ALL ACTIVITIES OF DAILY LIVING). THE PATIENT WAS ROLLED OVER ONTO HIS RIGHT SIDE. HIS WEIGHT WAS RESTING UP AGAINST THE SIDE RAIL. THE SIDE RAIL MADE A LARGE "POPPING" NOISE AND WENT DOWN. THE NURSE ON THAT SIDE OF THE BED WAS ABLE TO CATCH THE PATIENT, HELPED LOWER HIM TO THE GROUND, AND KEPT HIM FROM BEING HARMED. WE HAVE NOT HAD THIS PROBLEM WITH THIS DEVICE IN THE PAST. NO INJURY TO STAFF. PATIENT WEIGHED APPROXIMATELY 214 POUNDS WHICH IS WITHIN THE WEIGHT LIMIT FOR THIS DEVICE.======================MANUFACTURER RESPONSE FOR HILLROM TOTAL CARE BED, TOTAL CARE BED (PER SITE REPORTER).======================LOGGED THE EVENT.THERE WERE NO FUNCTIONAL ISSUES IDENTIFIED UPON INSPECTION. EVENT COULD NOT BE DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL CARE BED, HOSPITAL FNL HILL ROM P1900N006970 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *