BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINAIR

    MDR report key: 1226365 · Received November 11, 2008

    Report

    Report Number
    1625774-2008-00051
    Event Type
    Death
    Date Received
    November 11, 2008
    Date of Event
    October 11, 2008
    Report Date
    October 13, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY DID INDICATED THAT ONLY THE TWO UPPER SIDE RAILS WERE IN USE AT THE TIME OF THE ALLEGED EVENT. NO ADD'L INFO HAS BEEN PROVIDED BY THE FACILITY PENDING COMPLETION OF THEIR INTERNAL INVESTIGATION. THE BED WAS EVALUATED BY KCI SERVICE PERSONNEL AT THE FACILITY WHERE THE INCIDENT OCCURRED AND FOUND THE BED TO BE FUNCTIONING CORRECTLY. IT WAS CONCLUDED THE BED FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    IN 2008, THE FACILITY REPORTED THAT A FEMALE PT BEING TREATED FOR STAGE II SACRAL ULCER ON A KINAIR MEDSURG BED WAS DISCOVERED WITH HER FEET ON THE FLOOR AND HER HEAD TRAPPED BETWEEN THE CUSHION AND THE SIDE RAIL IN ZONE 4. UPON DISCOVERY, THE PT WAS REPORTEDLY WITHOUT A PULSE OR RESPIRATION. THE PT WAS RETURNED TO BED AND CODE BLUE CALLED. THE PT SUBSEQUENTLY PASSED AWAY. ACCORDING TO THE FACILITY, THE CAUSE OF DEATH AS RECORDED ON THE DEATH CERTIFICATE WAS ATHEROSCLEROTIC HEART DISEASE, DUE TO CONGESTIVE HEART FAILURE, DUE TO CORONARY ARTERY DISEASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death OPEN REDUCTION AND INTERNAL FIXATION