BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINAIR

    MDR report key: 2153055 · Received June 29, 2011

    Report

    Report Number
    1625774-2011-00079
    Event Type
    Death
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 9, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE BED PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS PRIOR TO PT PLACEMENT. ON (B)(6) 2011, THE BED WAS EVALUATED AT THE KCI SERVICE CENTER BY A KCI SERVICE CONSULTANT. THERE WAS NO EVIDENCE OF A DEFECT OR MALFUNCTION WITH THE BED. ALL FOUR SIDE RAILS WERE FULL LATCHING IN THE UPRIGHT AND MID POSITIONS AND FUNCTIONED AS DESIGNED. THE BED PASSED QC CHECKS AND MET SPECIFICATIONS. THE BED FUNCTIONED AS DESIGNED. KINAIR MEDSURG PULSE HAS AN EXIT ALARM BUTTON FEATURE WHERE A 10% OR MORE DECREASE IN PT WEIGHT IS DETECTED WHEN ACTIVATED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE RISK MANAGER REPORTED THE FOLLOWING TO KCI: ON (B)(6) 2011, THE NURSE LEFT THE SIDE RAILS DOWN ON THE BED AND AFTER AN UNK PERIOD OF TIME, THE PT FELL OUT OF THE BED. THE PT EXPERIENCED A CEREBRAL HEMORRHAGE FROM THE FALL AND SUBSEQUENTLY DIED LATER THAT DAY. THE RISK MANAGER REPORTED THAT THERE WAS NO MALFUNCTION OF THE BED; HOWEVER, THE NURSE TAKING CARE OF THE PT FAILED TO PLACE THE SIDE RAILS IN THE UP POSITION AS PER HOSPITAL PROTOCOL. MULTIPLE REQUESTS FOR ADDITIONAL INFO FROM THE ICU DIRECTOR AND RISK MANAGEMENT MANAGER BY KCI WERE DENIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINAIR IOQ KCI USA, INC. MEDSURG PULSE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death