BEUDAMED
    FDA Adverse Event Death Summary report: N

    MED MIZER RETRACTABED

    MDR report key: 1412556 · Received July 9, 2009

    Report

    Report Number
    MW5011827
    Event Type
    Death
    Date Received
    July 9, 2009
    Date of Event
    June 21, 2009
    Report Date
    June 25, 2009
    Manufacturer
    MED MIZER, INC.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    W.S. SLID FROM THE AIR MATTRESS ONTO THE FLOOR; WAS FOUND WITH HEAD BETWEEN SIDERAIL AND AIR MATTRESS. STAFF ENTERED ROOM TO FIND W.S ON FLOOR NEXT TO BED. RESIDENT HAD ARM EXTENDED BETWEEN BED RAIL AND MATTRESS AND HEAD BETWEEN BEDRAIL AND MATTRESS. NURSE CALLED FOR HELP; UNABLE TO OBTAIN APICAL PULSE; SHALLOW BREATHS NOTED. RESIDENT PLACED BACK IN BED AND STERNAL RUB INITIATED. RESIDENT EXPIRED WITHIN A FEW MINUTES. RESIDENT EXPERIENCED FALLS FROM BED/MATTRESS 2 PREVIOUS NIGHTS AS WELL. MATTRESS WAS PLACED ON BED DAY BEFORE FIRST FALL. ARM WAS CAUGHT IN SIDERAIL ON PREVIOUS FALL. UNOFFICIAL CAUSE OF DEATH IS DISRUPTION OF SPINAL COLUMN/CORD WITH DISLOCATION AT C3-C4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED MIZER RETRACTABED ELECTRIC BED FNL MED MIZER, INC. SS 802
    2 ROHO SELECT AIR MAX LOW AIR LOSS MATTRESS FNM THE ROHO GROUP ALISA2

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death