BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARROLL SOLO BED

    MDR report key: 1745755 · Received February 17, 2010

    Report

    Report Number
    1745755
    Event Type
    Death
    Date Received
    February 17, 2010
    Date of Event
    January 23, 2010
    Report Date
    February 4, 2010
    Manufacturer
    CARROLL HEALTHCARE INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT APPROX. 8 AM RN SUMMONED TO RM (B)(6) BY NURSING ASSISTANT UPON ENTERING THE ROOM RESIDENT WAS FACE DOWN WITH HEAD ON MATTRESS FACING THE ASSIST RAIL AND REMAINDER OF BODY WAS ON THE FALL MAT AT THE BEDSIDE. THE CHARGE NURSE ASSISTED THE RESIDENT TO THE FLOOR. THE RESIDENT WAS WITHOUT PULSE PARAMEDICS PRONOUNCED DEATH AT 8:25 AM. RAILS ON THE BED WERE IN ASSIST POSITION AND BED WAS IN LOW POSITION. THE DOLPHIN AIR MATTRESS WAS FUNCTIONING PROPERLY AND FALL MATS WERE IN PLACE. BODY ALARM WAS IN PLACE. FAMILY, PHYSICIAN, AND (B)(6) CORONER WERE CONTACTED. THE CORONER REPORTED THE CAUSE OF DEATH AS ACCIDENTAL MECHANICAL ASPHYXIATION. A MANDATORY REPORT WAS MADE TO DEPARTMENT OF HEALTH AND SURVEYOR NOTED NO DEFICIENT PRACTICE OR PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARROLL SOLO BED CARROLL BED FNL CARROLL HEALTHCARE INC. ECHO-111
    2 DOLPHIN AIR MATTRESS NONE FNM DISTRIBUTOR OF PRODUCT WOUND SYSTEMS 900T

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death PRAFO650 BOOTS ON BOTH FEET BECAUSE OF HEEL ULCERS