BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIRST STEP SELECT THERAPEUTIC OVERLAY

    MDR report key: 2602682 · Received May 30, 2012

    Report

    Report Number
    1625774-2012-00048
    Event Type
    Death
    Date Received
    May 30, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 8, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, THE UNIT PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS PRIOR TO PT PLACEMENT ON (B)(4) 2012. ON (B)(4) 2012, POST PLACEMENT, THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS. PRODUCT LABELING ON LINE AND IN PRINT STATES: MONITOR PATIENTS FREQUENTLY TO GUARD AGAINST PT ENTRAPMENT AND MIGRATION. USE OR NON-USE OF RESTRAINTS, INCLUDING SIDE RAILS, CAN BE CRITICAL TO PT SAFETY. 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. SERIOUS INJURY OR DEATH CAN RESULT FROM THE USE (POTENTIAL ENTRAPMENT) OR NON-USE (POTENTIAL PT FALLS) OF SIDE RAILS OR OTHER RESTRAINTS.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY A KCI REP: ON (B)(6) 2012, A NURSE STATED THAT ON (B)(6) 2012, THE PT ALLEGEDLY FELL OUT OF THEIR HOSPITAL BED. THE PT WAS REPORTED TO HAVE SUFFERED A HEAD INJURY AND IS NOW DECEASED. THE PT WAS ALSO UTILIZING A FIRST STEP SELECT THERAPEUTIC OVERLAY AT THE TIME OF THE INCIDENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO GAIN ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIRST STEP SELECT THERAPEUTIC OVERLAY IOQ KCI USA, INC. FIRST STEP SELECT

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death