BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIALTY BED - KINAIR

    MDR report key: 1233503 · Received October 26, 2008

    Report

    Report Number
    1233503
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 20, 2008
    Report Date
    October 26, 2008
    Manufacturer
    KINETIC CONCEPTS, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HOURLY SAFETY ROUNDS WERE PERFORMED. APPROXIMATELY 40 MINUTES LATER, DURING ANOTHER PATIENT CHECK, KINAIR BED FOUND TO BE COMPLETELY DEFLATED. ALL CONNECTIONS AND ELECTRIC CORDS CHECKED AND BED CORD MOVED FROM RED COVERED RECEPTACLE TO ANOTHER OUTLET ON ACCESSORY PANEL. BED WORKED AT THAT POINT. MAINTENANCE NOTIFIED TO CHECK PLUG AND KCI NOTIFIED OF BED MALFUNCTION. PROBLEM DISCUSSED WITH REP FROM KCI, AND SOLUTION WAS FOR NURSING TO CONTINUE TO MONITOR BED FREQUENTLY. TECHNICIAN OFFERED NEW BED PRN. PHYSICIAN NOTIFIED OF PROBLEM, NO ORDERS RECIEVED. PT EXAMINED AND NO ADVERSE CONDITIONS NOTED. CHARGE NURSE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECIALTY BED - KINAIR BED, AC-POWERED ADJUSTABLE HOSPITAL FNL KINETIC CONCEPTS, INC. 40030A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR