BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIRST STEP

    MDR report key: 1661794 · Received April 16, 2010

    Report

    Report Number
    1625774-2010-00027
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    May 25, 2008
    Report Date
    August 28, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    FNM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MATTRESS WAS TESTED PER QUALITY CONTROL PROCEDURES AND MET SPECS PRIOR TO PT PLACEMENT. THE MATTRESS WAS RETURNED TO THE KCI SERVICE CENTER AFTER THE ALLEGED EVENT AND TESTED PER QUALITY CONTROL PROCEDURES AND MET SPECS. THE FIRST STEP TRICELL SAFETY INFO STATES: "BED FRAME - ALWAYS USE A STANDARD HEALTHCARE BED FRAME WITH SAFEGUARDS OR PROTOCOLS THAT MAY BE APPROPRIATE. IT IS RECOMMENDED THAT BED AND SIDE RAILS (IF USED) COMPLY WITH THE HOSPITAL BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE ENTRAPMENT, 03/2006. (B) (4). FRAME AND SIDE RAILS MUST BE PROPERLY SIZED RELATIVE TO THE MATTRESS TO HELP MINIMIZE ANY GAPS THAT MIGHT ENTRAP A PT'S HEAD OR BODY." "PT MIGRATION - AS WITH ALL SPECIALTY BED PRODUCTS THAT ARE DESIGNED TO REDUCE SHEAR AND PRESSURE ON THE PT'S SKIN, THE RISK OF GRADUAL MOVEMENT AND/OR SINKING INTO HAZARDOUS POSITIONS OF ENTRAPMENT AND/OR INADVERTENT BED EXIT MAY BE INCREASED." THE FIRST STEP TRICELL SAFETY INFO STATES THE FOLLOWING: "SIDE RAILS/PT RESTRAINTS - WHETHER AND HOW TO USE SIDE RAILS IS A DECISION THAT SHOULD BE BASED ON EACH PT'S NEEDS AND SHOULD BE MADE BY THE PT AND THE PT'S FAMILY, PHYSICIAN, AND CAREGIVERS, WITH FACILITY PROTOCOLS IN MIND. CAREGIVERS SHOULD ASSESS RISKS AND BENEFITS OF BED RAIL/RESTRAINT USE (INCLUDING, ENTRAPMENT AND PT FALLS FROM BED) IN CONJUNCTION WITH INDIVIDUAL PT NEEDS, AND SHOULD DISCUSS USE OR NON-USE WITH PT AND/OR FAMILY. CONSIDER NOT ONLY THE CLINICAL AND OTHER NEEDS OF THE PT, BUT ALSO THE RISKS OF DEATH OR SERIOUS INJURY FROM FALLING OUT OF BED AND FROM PT ENTRAPMENT IN OR AROUND THE SIDE RAILS, RESTRAINTS, OR OTHER ACCESSORIES... CONSULT A CAREGIVER AND CAREFULLY CONSIDER THE USE OF BOLSTERS, POSITIONING AIDS, FLOOR PADS OR KCI PADDED SIDE RAIL ACCESSORIES, ESPECIALLY WITH CONFUSED, RESTLESS OR AGITATED PTS. IT IS RECOMMENDED THAT SIDE RAILS (IF USED) BE LOCKED IN THE FULL UPRIGHT POSITION WHEN THE PT IS UNATTENDED. MAKE SURE A CAPABLE PT KNOWS HOW TO GET OUT OF BED SAFELY (AND, IF NECESSARY HOW TO RELEASE THE SIDE RAILS) IN CASE OF FIRE OR OTHER EMERGENCY. MONITOR PTS FREQUENTLY TO GUARD AGAINST PT ENTRAPMENT AND MIGRATION."

    Description of Event or Problem · 1

    A (B) (6) FEMALE PT WITH ALZHEIMER'S DISEASE RECOVERING AT HOME FROM A BROKEN HIP USING A FIRST STEP TRICELL MATTRESS ON A BED FRAME (MFR UNK) WITH ONLY UPPER SIDE RAILS. THE FIRST STEP MATTRESS AND BED FRAME (MFR UNK) WERE ORDERED AND PROVIDED TO THE PT BY THEIR HEALTH CARE PROVIDER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADD'L INFO REGARDING THE BED FRAME USED WITHOUT SUCCESS. ACCORDING TO THE PT'S FAMILY MEMBER, THE PT EXITED THE BED ON THREE DIFFERENT OCCASIONS PRIOR TO THE REPORTED EVENT. AT 1:45 AM, IT WAS REPORTED THAT THE PT WAS FOUND PARTIALLY EXITED FROM THE BED AND NOT BREATHING. ACCORDING TO THE REPORT, EFFORTS TO REVIVE THE PT WERE UNSUCCESSFUL. THE FAMILY MEMBER STATED THAT THE PT DID NOT HAVE CONTROL OR UNDERSTANDING THAT THE MATTRESS WAS NOT FIRM (I.E., AIR SURFACE) AND COULD MOVE AROUND THE PT. IT IS UNK WHETHER THE PT WAS RECEIVING HOME HEALTH CARE AT THE TIME OF THE ALLEGED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST STEP FNM KCI USA, INC. TRICELL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death