BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIKORALL 242 S, WHITE

    MDR report key: 20002256 · Received August 20, 2024

    Report

    Report Number
    8030916-2024-00050
    Event Type
    Death
    Date Received
    August 20, 2024
    Date of Event
    July 27, 2024
    Report Date
    October 9, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    LIKORALL OVERHEAD LIFT IS INTENDED FOR USE IN, HEALTH CARE, INTENSIVE CARE AND REHABILITATION. LIKORALL OVERHEAD LIFT IS DESIGNED FOR FIXED INSTALLATION AND FREE-STANDING LIFT SYSTEMS. ALL COMMON LIFTS AND TRANSFERS CAN BE PERFORMED USING LIKORALL OVERHEAD LIFT, FOR INSTANCE BETWEEN BED/WHEELCHAIR, TO/FROM FLOOR, TOILET VISITS, GAIT TRAINING, AND TOGETHER WITH STRETCHERS. LIKORALL R2R OVERHEAD LIFT ENABLES THE PATIENT TO BE MOVED BETWEEN TWO RAIL SYSTEMS IN SEPARATE ROOMS. LIKORALL OVERHEAD LIFT WITH THE ES DESIGNATION IS PREPARED FOR OPERATION WITH THE WIRELESS HANDCONTROL REMOTE AND IN ADDITION, A TRANSFER MOTOR CAN BE CONNECTED FOR MOTOR DRIVEN MOVEMENT ALONG THE RAIL. LIKORALL S, IRC OVERHEAD LIFT IS PREPARED FOR CONTINUOUS CHARGING THROUGH THE RAILSYSTEM. THE DEVICE INSTRUCTIONS FOR USE STATE THE FOLLOWING REGARDING THE LIFTING ACCESSORY WITH QUICK-RELEASE HOOK: PUSH DOWN THE CATCH AND CONNECT THE QUICK-RELEASE HOOK TO THE Q-LINK II OR Q-LINK. RELEASE AND CHECK THAT THE CATCH LOCKS IN ORDER TO PREVENT INVOLUNTARY UNHOOKING FROM THE Q-LINK II OR Q-LINK. BEFORE LIFTING CHECK THAT THE QUICK-RELEASE HOOK IS CORRECTLY ATTACHED TO THE Q-LINK II OR Q-LINK. A BAXTER SERVICE TECHNICIAN INSPECTED THE DEVICE, WHICH WAS FOUND TO FUNCTION AS DESIGNED. THE SLING AND ACCESSORIES WERE AN APPROVED COMBINATION. FURTHER INSPECTION OF THE SLINGBAR IS PLANNED. IT WAS NOTED THAT DEVICE PREVENTIVE MAINTENANCE WAS LAST PERFORMED BY A THIRD PARTY ON 26 JUN 2024. IN THIS EVENT, A PATIENT FELL AND SUBSEQUENTLY DIED. THE CAUSE OF THE EVENT AND PATIENT DEATH IS UNDETERMINED. INSPECTION OF THE LIKORALL 242 FOUND THE DEVICE FUNCTIONED AS DESIGNED DURING INSPECTION BY BAXTER. THE BAXTER SERVICE TECHNICIAN RECOVERED THE SLINGBAR INVOLVED IN THE INCIDENT FOR FURTHER INVESTIGATION. AT THIS TIME, PRELIMINARY INSPECTION OF THE DEVICE HAS RULED OUT MALFUNCTION OR DEFECT, HOWEVER, BAXTER¿S INVESTIGATION IS ONGOING. PREVENTION OF THIS TYPE OF EVENT ARE OUTLINED IN THE DEVICE IFU AS NOTED ABOVE. ALL RELEVANT INFORMATION RECEIVED WILL BE PROVIDED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INJURY DETAILS HAVE NOT BEEN PROVIDED BY THE CUSTOMER. THE SLINGBAR INVOLVED IN THE REPORTED INCIDENT WAS RETURNED TO BAXTER FOR INSPECTION AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE SLINGBAR FUNCTIONED AS DESIGNED. THE INVESTIGATION CONCLUDED THE CAUSE OF THE EVENT WAS LIKELY DUE TO USE ERROR (INCORRECT ATTACHMENT OF THE QUICK RELEASE HOOK). THE UNIVERSAL SLINGBAR CAN BE USED IN COMBINATION WITH LIKO SLINGS THAT ATTACHES TO THE SLING BAR USING SLING LOOPS. LIKO UNIVERSAL SLING BARS ARE WITH TWO ASSEMBLY OPTIONS, FIXED ASSEMBLY OR WITH QUICK-RELEASE HOOK. THE LIKO UNIVERSAL SLING BARS INSTRUCTIONS FOR USE (7EN160185 REV. 5) STATES THE FOLLOWING UNDER CARE AND MAINTENANCE: FOR TROUBLE-FREE USE, CERTAIN DETAILS SHOULD BE CHECKED BEFORE EACH USE: WHEN USING A QUICK-RELEASE HOOK SYSTEM, CHECK THAT THE QUICK-RELEASE HOOK IS CORRECTLY FASTENED TO THE LIFT AND THE SLING BAR. ADDITIONAL TRAINING WAS SCHEDULED WITH THE CUSTOMER. ALTHOUGH THERE WAS NO DEVICE MALFUNCTION AND THE INCIDENT WAS LIKELY CAUSED BY INCORRECT ATTACHMENT OF THE QUICK RELEASE HOOK, IF THE INCIDENT WERE TO RECUR IT WOULD COULD CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS PATIENT DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAREGIVER WAS TRANSFERRING A (B)(6) YEAR-OLD MALE PATIENT FROM A WHEELCHAIR TO A COMFORT CHAIR USING A LIKORALL 242 WHEN THE SLINGBAR QUICK-RELEASE HOOK CAME UNHOOKED, AND THE PATIENT FELL TO THE FLOOR. THE INCIDENT OCCURRED ON(B)(6) 2024 AT 13:00 AND THE PATIENT SUSTAINED HEMATOMAS ON THE BUTTOCKS. THAT SAME DAY, THE PATIENT WAS PLACED UNDER SURVEILLANCE AND WAS LATER TAKEN TO THE EMERGENCY ROOM WHERE HE DIED. AFTER THIS INCIDENT, THE SLINGBAR WAS USED UNTIL THE INCIDENT WAS REPORTED ON 05 AUG 2024. ATTEMPTS TO OBTAIN DETAILS OF THE CLINICAL COURSE OF EVENT FOLLOWING THE FALL, INCLUDING CAUSE OF DEATH, ARE IN PROGRESS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CAREGIVER WAS TRANSFERRING A (B)(6)-YEAR-OLD MALE PATIENT FROM A WHEELCHAIR TO A COMFORT CHAIR USING A LIKORALL 242 WHEN THE SLINGBAR QUICK-RELEASE HOOK CAME UNHOOKED, AND THE PATIENT FELL TO THE FLOOR. THE INCIDENT OCCURRED ON (B)(6) 2024 AT 13 :00 AND THE PATIENT SUSTAINED HEMATOMAS ON THE BUTTOCKS. THAT SAME DAY, THE PATIENT WAS PLACED UNDER SURVEILLANCE AND WAS LATER TAKEN TO THE EMERGENCY ROOM WHERE HE DIED. AFTER THIS INCIDENT, THE SLINGBAR WAS USED UNTIL THE INCIDENT WAS REPORTED ON (B)(6) 2024. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396767 LIKORALL 242 S, WHITE LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3122010

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Death