BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA FLEX

    MDR report key: 20607942 · Received November 5, 2024

    Report

    Report Number
    9681684-2024-00077
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    August 5, 2024
    Report Date
    December 5, 2024
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT WAS TRANFERED FROM A COMMODE TO THE CHAIR. DURING THE TRANSFER THE RESIDENT¿S RIGHT FOOT APPARENTLY MOVED AWAY FROM THE FOOTPLATE. THIS RESULTED IN THE RESIDENT NOT MOVING TO A STANDING POSITION. INSTEAD, THE RESIDENT SLOWLY DESCENDED TO A SQUATTING POSITION. THE TWO ASSISTING CAREGIVERS COULDN'T MOVE THE RESIDENT UP, SO THEY SLOWLY LOWERED HER TO THE FLOOR. IT WAS NOT ESTABLISHED WHETHER THE RESIDENT WAS WEARING FOOTWEAR AT THE TIME OF THIS INCIDENT. AS A RESULT OF THIS INCIDENT, THE RESIDENT WAS REPORTED TO HAVE SUSTAINED FRACTURES TO HER RIGHT LOWER LEG AND LEFT HIP WHICH WERE TREATED IN HOSPITAL. THE LEG STRAP IS LOCATED UNDER THE SILICONE LEG SUPPORT. THE LEG STRAP IS USED TO MAKE SURE THAT THE PATIENT¿S LEGS STAY CLOSE TO THE LEG SUPPORT. THE INSTRUCTION FOR USE (IFU) FOR SARA FLEX DEVICE CONTAINS A GRAPHICAL EXPLANATION REGARDING LEG STRAP ATTACHMENT TO THE LIFT. ¿ATTACHED THE LEG STRAP TO SUPPORT THE PATIENT¿S LEGS, IF NEEDED. ¿ ¿TO FASTEN THE LEG STRAP, ATTACHED IT TO THE ATTACHMENT POINT ON EITHER SIDE OF THE LEG SUPPORT.¿ MOREOVER THE IFU STATES THAT BEFORE USE THE CAREGIVER SHOULD ALWAYS CONSIDER THE PATIENTS/RESIDENTS MEDICAL CONDITION, PHYSICAL AND MENTAL CAPABILITIES. IN ADDITION, THE PATIENT/RESIDENT MUST BE ABLE TO BEAR WEIGHT ON AT LEAST ONE LEG AND HAVE SOME TRUNK STABILITY TO USE THE SARA FLEX DEVICE. IF PATIENT IS NOT SUITABLE FOR THE TRANSFER AND NOT MET ABOVE CRITERIA, THE OTHER TYPE OF LIFT SHOULD BE USED FOR PATIENT TRANSFER. THE DEVICE WAS NOT AVAILABLE FOR THE INSPECTION BY ARJO. THE ROOT CAUSE OF THE REPORTED EVENT IS IMPOSSIBLE TO DEFINE. TO SUM UP, IT HAS BEEN ESTABLISHED THAT A FLOOR LIFT AND SLING WERE USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT. NO DEVICE MALFUNCTION WAS REPORTED WHICH MIGHT LEAD TO REPORTED PATIENT INJURY. THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE REPORTED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS REQUIRED TO BE SEND WITH CORECTED CUSTOMER DETAILS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. H3 OTHER TEXT : THE CUSTOMER WAS NOT ABLE TO FIND THE LIFT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING AN ARJO SARA FLEX STANDING HOIST TO TRANSFER A RESIDENT FROM A COMMODE TO HER DAY CHAIR IN THE ROOM, THE RESIDENT¿S RIGHT FOOT APPARENTLY MOVED FROM THE FOOTPLATE. THIS RESULTED IN THE RESIDENT NOT MOVING TO THE STANDING POSITION AND INSTEAD SLOWLY DESCENDING DOWNWARDS. AS A RESULT, THE RESIDENT DID NOT MOVE TO THE STANDING POSITION, BUT INSTEAD SLOWLY DESCENDED. THE TWO CAREERS ASSISTING COULDN'T GET RESIDENT UP, SO THEY SLOWLY LOWERED HER UNTIL SHE WAS LYING ON HER BACK ON THE FLOOR. AS A CONSEQUENCE OF THIS INCIDENT, THE RESIDENT SUSTAINED FRACTURES TO HER RIGHT LOWER LEG AND LEFT HIP WHICH WERE TREATED IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1626954 SARA FLEX LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Hospitalization