BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIKORALL 242 S, NATURAL

    MDR report key: 5413874 · Received February 5, 2016

    Report

    Report Number
    8030916-2016-00015
    Event Type
    Death
    Date Received
    February 5, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 18, 2016
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM HAS COMPLETED MECHANICAL TESTING AND VISUAL INSPECTION ON THE RETURNED LIKORALL 242 S LIFT. THE LIFT IS FULLY FUNCTIONAL WITH REGARDS TO VERTICAL MOVEMENT AND EMERGENCY LOWERING, ACCORDING TO LIKO SPECIFICATIONS. THE LIFT STRAP WAS CORRECTLY ASSEMBLED, BUT SIGNS OF A FORMER ASYMMETRICAL FOLD MARK INDICATES THAT THE LIFT STRAP HAS BEEN IMPROPERLY WOUND TO THE DRUM AT SOME POINT. ACCORDING TO 7EN120115 REV 7 "USER MANUAL LIKORALL 242/243/250", HILL-ROM STATES THAT BEFORE LIFTING, ALWAYS ENSURE THAT THE LIFT STRAP IS NOT TWISTED OR WORN AND CAN MOVE IN AND OUT OF THE LIFT FREELY. OTHER POSSIBLE CAUSES FOR THE UNEXPECTED LOWERING OF A PATIENT COULD BE DUE TO AN INCORRECT USAGE OF THE SLING (THE SLING DID NOT MEET THE PATIENT´S NEED WITH REFERENCE TO MODEL AND SIZE OR TYPE OF SLING USED FOR THE LIFT SITUATION). THE LIKO HYGIENESLING THAT WAS USED IS DESIGNED TO ASSIST WITH DRESSING AND UNDRESSING OF A PATIENT WHEN LIFTING THEM TO AND FROM THE TOILET. THE HYGIENESLING IS NOT INTENDED TO BE USED WHEN LIFTING FROM A FLAT SURFACE SINCE IT DOES NOT PROVIDE THE PATIENT WITH ANY HEAD SUPPORT. THIS SITUATION WILL REQUIRE THE PATIENT TO ENGAGE THEIR VENTRAL NECK MUSCLES IN ORDER TO HOLD THEIR HEAD UP. AN ELDERLY, WEAK PATIENT COULD HAVE CONSIDERABLE PROBLEMS ACHIEVING THIS, RESULTING IN THE PATIENT'S HEAD FALLING BACK UNSUPPORTED. ACCORDING TO 7EN160186 REV 4 "INSTRUCTION GUIDE HYGIENESLING, MOD. 40, 41", HILL-ROM STATES THAT IT SHALL BE ENSURED THAT THE LIFTING ACCESSORIES ARE SUITABLE FOR THE LIFT USED. IT IS NECESSARY TO HAVE GOOD BODY STABILITY TO SIT WELL IN THE HYGIENESLING. IT IS NOT STATED HOW TO PERFORM A LIFT FROM A FLAT SURFACE, SINCE IT IS NOT RECOMMENDED TO USE A HYGIENESLING FOR SUCH A LIFT. WHEN A PATIENT NEEDS TO BE REPOSITIONED HIGHER UP IN THE BED (SUCH AS IN THIS SITUATION), IT IS RECOMMENDED TO USE ONE OF LIKO´S REPOSITIONING AIDS: REPOSHEET OR HANDYTUBES. THE AID TO SELECT IS MAINLY DEPENDENT ON THE DEGREE TO WHICH THE PERSON CAN ASSIST DURING THE REPOSITIONING, WHICH SHOULD BE DETERMINED THROUGH A CLINICAL RISK ASSESSMENT BEFORE LIFTING. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    WHEN THE HILL-ROM TECHNICIAN INVESTIGATED THE PRODUCT, NO FAILURE WAS DETECTED. THE LIFT FUNCTIONED AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS LIFT'S MOTOR IN APRIL 2015. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFTS. THE HILL-ROM TECHNICIAN DID NOT FIND ANY FAILURE OF THE LIFT. HILL-ROM HAS REQUESTED THE ACCOUNT TO RETURN THE LIFT, LIFT STRAP, SLING BAR AND HAND CONTROL FOR ADDITIONAL INVESTIGATION. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING WHILE LOWERING THE PATIENT TO THE MATTRESS, THE CAREGIVER NOTICED THE PATIENT WAS NOT CORRECTLY POSITIONED ON THE BED AND THEY TRIED TO REPOSITION HER ON THE BED USING THE SLING. A CAREGIVER ACTIVATED THE BUTTON TO LOWER THE SLING WHEN IT LOWERED UNEXPECTEDLY. THE PATIENT HIT HER HEAD ON THE HEAD SECTION OF THE BED CAUSING A LACERATION REQUIRING SUTURES. THE PATIENT DIED 24 HOURS AFTER THE INCIDENT. THE ACCOUNT WAS UNABLE TO PROVIDE SUFFICIENT INFORMATION TO HILL-ROM IN ORDER TO DETERMINE IF HER DEATH IS RELATED TO THE ABOVE INCIDENT. THE LIFT WAS LOCATED IN THE PATIENT ROOM AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING WHILE LOWERING THE PATIENT TO THE MATTRESS, THE CAREGIVER NOTICED THE PATIENT WAS NOT CORRECTLY POSITIONED ON THE BED AND THEY TRIED TO REPOSITION HER ON THE BED USING THE SLING. A CAREGIVER ACTIVATED THE BUTTON TO LOWER THE SLING WHEN IT LOWERED UNEXPECTEDLY. THE PATIENT HIT HER HEAD ON THE HEAD SECTION OF THE BED CAUSING A LACERATION REQUIRING SUTURES. THE PATIENT DIED 24 HOURS AFTER THE INCIDENT. THE ACCOUNT WAS UNABLE TO PROVIDE SUFFICIENT INFORMATION TO HILL-ROM IN ORDER TO DETERMINE IF HER DEATH IS RELATED TO THE ABOVE INCIDENT. THE LIFT WAS LOCATED IN THE PATIENT ROOM AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72089 LIKORALL 242 S, NATURAL NON-AC POWERED PATIENT LIFT FSA LIKO AB 3122009

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death