BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERICAN STANDARD

    MDR report key: 434663 · Received December 27, 2002

    Report

    Report Number
    434663
    Event Type
    Malfunction
    Date Received
    December 27, 2002
    Date of Event
    March 13, 2002
    Report Date
    April 4, 2002
    Manufacturer
    AMERICAN STANDARD
    Product Code
    IKW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TITLE: PATIENT FALL DUE TO BROKEN TOILET SEAT. THE PATIENT WAS USING A [PERMANENT] COMMODE AND A RAISED TOILET SEAT [WITH ARMS]WHICH WAS BROKEN. [THE SEAT BROKE AWAY AT THE HINGE WHICH WAS VISIBLE ONLY UPON CLOSE INSPECTION AFTER THE PATIENT HAD FALLEN.] THE PATIENT SLIPPED AND FELL OFF OF THE SEAT AND BUMPED THEIR HEAD. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND XRAYS. [THIS PERMANENT COMMODE WAS LOCATED IN THE PATIENT BATHROOM. NORMAL WEAR WAS STATED AS A CAUSE BUT THERE WERE NO VISIBLE SIGNS OF DISREPAIR. THE INSPECTION PROCESS FOR THIS TYPE OF DEVICE IS EVERY 12 MONTHS DURING SCHEDULED ROOM INSPECTIONS. THE PATIENT DID NOT HAVE ASSISTANCE IN USING THE DEVICE AT THE TIME OF THE EVENT. THIS HAS NOT HAPPENED WITH THIS DEVICE PREVIOUSLY AT THIS FACILITY. THERE WERE NO UNUSUAL CIRCUMSTANCES OR ACTIVITIES SURROUNDING THIS EVENT]. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Description of Event or Problem · 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERICAN STANDARD TOILET IKW AMERICAN STANDARD * *
    2 AMERICAN STANDARD TOILET LID [RAISED TOILET SEAT] IKW AMERICAN STANDARD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other ATIVAN, LEVAQUIN.
    2 *