BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNO

    MDR report key: 3111207 · Received May 8, 2013

    Report

    Report Number
    8030916-2013-00024
    Event Type
    Death
    Date Received
    May 8, 2013
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO HILL-ROM THAT A PATIENT FELL WHILE BEING LIFTED IN A HILL-ROM/LIKO UNO 102 LIFT BY TWO CAREGIVERS IN (B)(6). IT WAS REPORTED THE PATIENT DIED AFTER THE INCIDENT. THE INVESTIGATION INCLUDED A HILL-ROM CLINICAL EMPLOYEE WHO INTERVIEWED STAFF AT THE FACILITY ABOUT THE ALLEGED INCIDENT. ACCORDING TO THE FACILITY MANAGER, THE APPARENT CAUSE OF THE PATIENT FALLING AND SUSTAINING FATAL INJURIES, WAS THE FAILURE TO SECURELY HOOK THE SLING TO THE SLINGBAR. THE (B)(6) POLICE HAVE RETAINED THE SLING AS PART OF THE INVESTIGATION, BUT INITIAL REPORTS SUGGEST THERE WAS NO FAULT WITH THE SLING INTEGRITY. NO OTHER DETAILS ARE AVAILABLE AT PRESENT TO ASCERTAIN IF THE CORRECT SLING HAD BEEN USED. THE STAFF INVOLVED HAD ALLEGED THE PATIENT WAS VERY AGITATED AND THEY THOUGHT AS THE PATIENT'S FEET MET THE BED SURFACE, HE WAS ABLE TO LIFT HIS WEIGHT ENABLING THE SLING STRAPS TO LIFT FREE OF THE RETAINERS. THE LIFT HAS BEEN QUARANTINED BY THE FACILITY AND HAD YET NOT ALLOWED HILL-ROM TO INVESTIGATE THIS LIFT IN PERSON. THE FACILITY REPORT REFERS ONLY TO A MINOR FAULT IDENTIFIED WITH THE MANUAL RELEASE MECHANISM NOT RELATED TO THE SLINGBAR/SLING INTERFACE. THE STRUCTURE OF THE HOIST BODY, ARM AND SLING RETAINER CLIPS APPEAR INTACT AND FIT FOR PURPOSE. IT WAS REPORTED TO HILL-ROM THAT THE STAFF INVOLVED WITH THE INCIDENT HAVE SINCE RECEIVED ADDITIONAL TRAINING IN RELATION TO THEIR MOVING AND HANDLING EQUIPMENT. HILL-ROM HAS BEEN ADVISED BY THE FACILITY THAT THEY WOULD BE CONDUCTING AN INVESTIGATION INDEPENDENT OF HILL-ROM IN CONSULTATION WITH (B)(6). HILL-ROM WILL SEND A FOLLOW-UP REPORT WHEN THIS INVESTIGATION IS COMPLETED AND WE ARE MADE AWARE OF THE RESULTS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202169 UNO NON-AC POWERED PATIENT LIFT FSA LIKO AB

    Patients

    Seq Age Sex Outcome Treatment
    1