BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINAIR MEDSURG

    MDR report key: 1702659 · Received May 9, 2010

    Report

    Report Number
    1702659
    Event Type
    Malfunction
    Date Received
    May 9, 2010
    Date of Event
    February 28, 2010
    Report Date
    May 9, 2010
    Manufacturer
    KCI USA, INC
    Product Code
    INX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE WHEELS WOULD NOT LOCK ON A KCI LOW AIR LOSS BED IN SICU. WHEN CARE GIVER LEANED ON BED IT WOULD MOVE EASILY. MATTRESS IS SUCH THAT WHEN THE MATTRESS IS ON MAX INFLATE THE PATIENT SLIDES EASILY ON THE MATTRESS. COMBINED WITH THE BED MOVING, BOTH THE CARE GIVER AND THE PATIENT ARE AT RISK FOR INJURY. VENDOR PERSONNEL DID DEMONSTRATE THE PROPER PROCEDURE FOR LOCKING THE WHEELS HOWEVER, ONLY THE WHEELS AT THE LOWER END OF THE BED LOCK. THE TWO AT THE HEAD END DO NOT. VENDOR PERSONNEL ADMITTED THIS IS TRUE OF ALL OF THESE BEDS. CO-WORKERS CONFIRMED THEY HAVE THE SAME ISSUE IN OTHER ROOMS WITH SIMILAR BEDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR MEDSURG BED, AIR FLUIDIZED INX KCI USA, INC KINAIR MEDSURG *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR