BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL SLING

    MDR report key: 14433243 · Received May 18, 2022

    Report

    Report Number
    8030916-2022-00024
    Event Type
    Death
    Date Received
    May 18, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 25, 2022
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP WITH THE CUSTOMER REVEALED THAT ON THE DAY OF THE INCIDENT, THE STAFF HOOKED THE LEG STRAPS OF THE SLING FIRST (PER CUSTOMER, SHOULDER STRAPS SHOULD BE HOOKED FIRST), THEN THE SHOULDER STRAPS, AND THE PATIENT WAS LIFTED OFF THE BED. NO SLACK WAS NOTED IN THE SLING, AND IT WAS BELIEVED THE SLING WAS HOOKED CORRECTLY. THE PATIENT REPORTEDLY HAS A LARGE PANNUS THAT DROPS TO HER RIGHT SIDE AND LEADS TO RIGHT TRUNK ROTATION. DUE TO THIS, AND TO HELP WITH PROPPING THE PATIENT UP, THE PATIENT PLACES HER RIGHT ARM OUTSIDE OF THE SLING AND ONCE SHE IS LIFTED, SHE BRINGS HER RIGHT ARM BACK IN. THE PATIENT WAS A 3-PERSON ASSIST; ONE STAFF MEMBER WOULD STAND BEHIND THE PATIENT AND TILT THE WHEELCHAIR BACK 60 DEGREES WITH THE TWO OTHER STAFF MEMBERS ON EITHER SIDE OF THE PATIENT TO ASSIST WITH GUIDING THE PANNUS AND REST OF HER BODY TO THE WHEELCHAIR. THE PATIENT WAS FULLY SUSPENDED AND BEING MOVED TOWARDS HER POWER CHAIR, WHICH WAS 1-1.5 METERS FROM THE BED, WHEN THE LEFT LEG STRAP CAME OFF AND A SNAPPING SOUND WAS HEARD BY STAFF. THE PATIENT¿S RIGHT LEG WAS NOTED TO BE CAUGHT IN THE RIGHT LEG STRAP. THE PATIENT BEGAN ROLLING TO THE LEFT SO STAFF PUSHED HER TO THE RIGHT, MOVED THE PATIENT AWAY FROM THE POWER CHAIR, AND THE PATIENT¿S HEAD WAS GUIDED DOWN A STAFF MEMBER¿S LEGS. WHEN THE PHYSIOTHERAPIST ENTERED THE ROOM, THE PATIENT WAS IN THE RECOVERY POSITION ON HER LEFT SIDE. PRELIMINARY INVESTIGATIONS REVEALED THE LIFT USED IN THE INCIDENT WAS A GULDMANN LIFT AND WAS INSTALLED IN AUGUST OR SEPTEMBER 2021. GULDMANN WORKED WITH THE CUSTOMER TO FIND BEST SLING FOR THIS PATIENT AS THERE IS NO REQUIREMENT BY GULDMANN TO USE THEIR SLING. THE CUSTOMER STATED THEY CONSIDERED MAKING A CUSTOM SLING FOR THIS PATIENT BUT CHOSE THE LIKO UNIVERSAL XL SLING. A LIFT TEST WAS PERFORMED BY GULDMANN IN JANUARY OF 2022 AT THE REQUEST OF STAFF OUT OF CAUTION DUE THE PATIENT¿S WEIGHT. THE SLING INVOLVED IN THIS INCIDENT WAS PUT INTO SERVICE IN NOVEMBER 2019 AND WAS LAST INSPECTED IN JUNE 2021. AN INSPECTION OF THE LIFT MOTOR, SLING BAR, AND SLING WAS PERFORMED BY THE CUSTOMER MAINTENANCE TEAM POST-INCIDENT. NO LURCH IN THE MOTOR OR SUDDEN DROP WAS FOUND. NO ISSUES WERE FOUND WITH ANY OF THE DEVICES INVOLVED IN THE INCIDENT. THE CUSTOMER HAS INVESTIGATED THE EVENT INTERNALLY BUT SO FAR, A ROOT CAUSE HAS NOT BE IDENTIFIED. IT IS BELIEVED THE LEG STRAP MAY HAVE COME LOOSE AND SLIPPED OFF THE SLING BAR PRIOR TO THE TRANSFER. BASED ON THE INFORMATION CURRENTLY AVAILABLE, NO MALFUNCTION OF THE SLING WAS ALLEGED OR IDENTIFIED DURING INSPECTION OF THE DEVICE BY THE CUSTOMER. THE PATIENT'S DEATH MAY BE ATTRIBUTED TO MISUSE OF THE DEVICE: THE LIKO UNIVERSAL SLING WAS USED WITH A COMPETITOR PRODUCT, WHICH THE DEVICE LABELING SPECIFICALLY WARNS AGAINST. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES TO CONNECT THE UPPER STRAPS TO THE SLING BAR HOOKS FIRST, FOLLOWED BY THE LEG SUPPORT LOOPS. HOWEVER, SINCE A LIKO UNIVERSAL SLING WAS INVOLVED IN AN EVENT THAT LED TO PATIENT DEATH, HILLROM CONSIDERS THIS A REPORTABLE EVENT. INVESTIGATION IS STILL ONGOING. HILLROM IS CONTINUING TO GATHER ADDITIONAL INFORMATION ON THE DEVICES INVOLVED IN AN EFFORT TO COMPLETE A THOROUGH INVESTIGATION TO IDENTIFY ALL POSSIBLE DEVICE ISSUES AND ROOT CAUSES. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    HILLROM HAS COMPLETED THE INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, NO MALFUNCTION OF THE SLING WAS ALLEGED OR IDENTIFIED DURING INSPECTION OF THE DEVICE BY THE CUSTOMER. THE LIKO UNIVERSAL SLING INVOLVED IN THIS INCIDENT WAS CONFIRMED TO BE IN GOOD WORKING CONDITION AND THERE WAS NO FAILURE OR MALFUNCTION OF THE DEVICE. THE PATIENT'S DEATH MAY BE ATTRIBUTED TO MISUSE OF THE DEVICE: THE LIKO UNIVERSAL SLING WAS USED WITH A COMPETITOR PRODUCT, WHICH THE DEVICE LABELING SPECIFICALLY PROHIBITS. ADDITIONALLY, THE INSTRUCTIONS FOR USE STATES TO CONNECT THE UPPER STRAPS TO THE SLING BAR HOOKS FIRST, FOLLOWED BY THE LEG SUPPORT LOOPS. HOWEVER, SINCE A LIKO UNIVERSAL SLING WAS INVOLVED IN AN EVENT THAT LED TO PATIENT DEATH, HILLROM CONSIDERS THIS A REPORTABLE EVENT. BASED ON THE INVESTIGATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A TRANSFER OF A BARIATRIC PATIENT, THE SLING'S LEG STRAP DETACHED FROM THE LIFT'S SLING BAR, CAUSING THE PATIENT TO FALL. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY THE FOLLOWING DAY, DUE TO THE CONSEQUENCES OF THE FALL. THE PATIENT WAS A (B)(6) FEMALE WEIGHING (B)(6) WITH A BMI VALUE BETWEEN 80 AND 90. THE PATIENT HAD A COMPLEX MEDICAL HISTORY, BUT THE CUSTOMER DECLINED TO PROVIDE DETAILS. THE PATIENT WAS CONSCIOUS AFTER THE FALL AND CHOSE NOT TO GO TO THE HOSPITAL (DUE TO POOR EXPERIENCE IN THE PAST). THE PATIENT WAS PLACED BACK IN BED USING THE SAME SLING. THE PATIENT¿S RIGHT KNEE HAD VISIBLE SWELLING AND BRUISING, BUT NO OBVIOUS BONE DEFORMITY WAS NOTED. THE PATIENT¿S PHYSICIAN CAME IN AND SAW THE PATIENT THE EVENING OF THE FALL ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT DIED. DETAILS OF THE PATIENT¿S DEATH WERE NOT PROVIDED. THE CUSTOMER DECLINED TO PROVIDE INFORMATION IF THE PATIENT¿S CONDITION DETERIORATED OR IF THE PATIENT WAS FOUND UNRESPONSIVE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING A TRANSFER OF A BARIATRIC PATIENT, THE SLING'S LEG STRAP DETACHED FROM THE LIFT'S SLINGBAR, CAUSING THE PATIENT TO FALL. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY THE FOLLOWING DAY, DUE TO THE CONSEQUENCES OF THE FALL. THE PATIENT WAS A 65-YEAR-OLD FEMALE WEIGHING 545 LB WITH A BMI VALUE BETWEEN 80 AND 90. THE PATIENT HAD A COMPLEX MEDICAL HISTORY, BUT THE CUSTOMER DECLINED TO PROVIDE DETAILS. THE PATIENT WAS CONSCIOUS AFTER THE FALL AND CHOSE NOT TO GO TO THE HOSPITAL (DUE TO POOR EXPERIENCE IN THE PAST). THE PATIENT WAS PLACED BACK IN BED USING THE SAME SLING. THE PATIENT¿S RIGHT KNEE HAD VISIBLE SWELLING AND BRUISING, BUT NO OBVIOUS BONE DEFORMITY WAS NOTED. THE PATIENT¿S PHYSICIAN CAME IN AND SAW THE PATIENT THE EVENING OF THE FALL ON ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT DIED. DETAILS OF THE PATIENT¿S DEATH WERE NOT PROVIDED. THE CUSTOMER DECLINED TO PROVIDE INFORMATION IF THE PATIENT¿S CONDITION DETERIORATED OR IF THE PATIENT WAS FOUND UNRESPONSIVE. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260455 UNIVERSAL SLING LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3301040

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Death