BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELUXE KD ALUMINUM BATHSEAT

    MDR report key: 2427212 · Received January 20, 2012

    Report

    Report Number
    2427212
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 20, 2012
    Manufacturer
    MEDICAL DEPOT DBA DRIVE MEDICAL DESIGN AND MANUFACTURING
    Product Code
    KMN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD PATIENT ALERT AND ORIENTED (A & O) X3 WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND OBESITY WAS ASSISTED TO THE SHOWER BY THE NURSE ASSISTANT (NA). THE PATIENT WAS SITTING ON THE CHAIR (BATH SEAT) WHEN THE METAL LEFT POSTERIOR LEG OF THE CHAIR GAVE WAY AND BENT TO A 45 DEGREE ANGLE. THE NA ASSISTED THE PATIENT TO THE FLOOR AND THERE WAS NO OBVIOUS INJURY TO THE PATIENT. THE PATIENT WAS THEN ASSISTED TO STANDING POSITION WITH STAFF ASSISTANCE AND THE BROKEN CHAIR WAS REMOVED FROM SERVICE AND REPLACED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELUXE KD ALUMINUM BATHSEAT DELUXE KD ALUMINUM BATH SEAT KMN MEDICAL DEPOT DBA DRIVE MEDICAL DESIGN AND MANUFACTURING 12202-4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR