BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIRSTSTEP

    MDR report key: 3111965 · Received May 18, 2007

    Report

    Report Number
    1625774-2006-00019
    Event Type
    Death
    Date Received
    May 18, 2007
    Date of Event
    February 20, 2007
    Report Date
    April 17, 2007
    Manufacturer
    KCI USA, INC.
    Product Code
    IOQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MANAGER OF THE FACILITY WHERE THIS EVENT OCCURRED INDICATES THAT THE PATIENT WAS TERMINALLY ILL WITH MULTIPLE MEDICAL PROBLEMS. THE PATIENT WAS VERY SMALL AND MALNOURISHED (81 POUNDS). THE EVENT WAS NOT OBSERVED. THE PATIENT WAS FOUND ON NURSING ROUNDS BETWEEN THE SPLIT SIDE RAIL OF THE BED FRAME IN THE SITTING POSITION ON THE FLOOR WITH HER LEGS EXTENDED; ALL FOUR SIDE RAILS WERE UP. THERE WERE NO BOLSTERS BEING USED; THE SIDE RAILS WERE PADDED WITH BLANKETS. THE RISK MANAGER FURTHER INDICATES THAT THE MAJOR FACTORS THAT CONTRIBUTED TO THIS INCIDENT ACCORDING TO THEIR INTERNAL INVESTIGATION WERE THE SPACE BETWEEN THE SIDE RAILS (8 INCH GAP), THE VEST DEVICE AND THE PATIENT'S RESTLESS CONDITION. "THE FIRSTSTEP WAS NOT IMPLICATED AS A CAUSATIVE FACTOR." ALTHOUGH THE FIRSTSTEP WAS NOT IMPLICATED AS A CAUSATIVE FACTOR, ACCORDING TO (B)(4): "WITHOUT REGARD TO WHETHER THE KCI PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY, ANY DEATH OR SERIOUS INJURY ASSOCIATED WITH PARTIAL OR COMPLETE EXIT FROM A KCI SURFACE OR BED WILL BE REPORTED."

    Description of Event or Problem · 1

    KCI BECAME AWARE OF THIS EVENT FROM A MAUDE EVENT REPORT, IT WAS NOT REPORTED DIRECTLY TO KCI BY THE HOSPITAL. IT WAS REPORTED THAT A TERMINALLY ILL PATIENT WHO WAS CONFUSED AND RESTLESS WAS ON A FIRSTSTEP SURFACE THAT WAS PLACED ON A HILL-ROM CENTURY CC BED FRAME FOR "COMFORT IN HER LAST DAYS." SINCE THE PATIENT HAD EXPERIENCED FALLS IN THE PAST, THE PHYSICIAN ALSO ORDERED A VEST RESTRAINT. THE PATIENT WAS FOUND EXPIRED ON NURSING ROUNDS. SHE WAS BETWEEN THE SPLIT SIDE RAILS OF THE BED FRAME (ZONE 5) WITH HER BUTTOCKS AND EXTENDED LEGS ON THE FLOOR AND HER BACK AGAINST THE BED. THE VEST RESTRAINT WAS STILL IN PLACE. THERE WAS NO MEDICAL INTERVENTION BECAUSE THE PATIENT WAS A DNR (DO NOT RESUSCITATE) AND ONLY PALLIATIVE MEASURES WERE BEING DONE. THERE WAS NO AUTOPSY AT THE FAMILY'S REQUEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DE ROYAL SLEEVED VEST| HILL-ROM CENTURY CC BED FRAME