BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINILIFT160

    MDR report key: 8055206 · Received March 2, 2018

    Report

    Report Number
    3009481053-2018-00014
    Event Type
    Injury
    Date Received
    March 2, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION WAS CONDUCTED WITH INPUT FROM USER FACILITY. THE DEVICE LAG SUPPORTS WERE. NOT CORRECTLY ADJUSTED BEFORE USA. BY PLACING THE FEET TOO FAR BACK ON THE FOOTPLATE, THE USER'S LAGS WERE NOT PROPERLY SUPPORTED BY THE LEG SUPPORTS WHILE BEING RISEN TO STANDING POSITION. THE USER'S FEET WERE PUSHED FURTHER BACK ON THE FOOTPLATE AND HIS KNEES BEGAN TO FOLD UNTIL THEY RESTED ON TOP OF THE LAG SUPPORTS. NO INJURY OCCURRED DURING THIS EVENT. THE INSTRUCTIONS FOR USE ADVISE THE USER/CAREGIVER TO ENSURE THAT LAG SUPPORTS ARE CORRECTLY ADJUSTED BEFORE USE AND TO ENSURE THAT THE USER'S SHINS ARE CORRECTLY POSITIONED TO THE LEG SUPPORTS. THE CAREGIVERS HAD RECEIVED TRAINING ON HOW TO USE THE DEVICE BEFORE THIS EVENT. HANDICARE OFFERED FURTHER TRAINING TO THE CAREGIVERS AFTER THIS EVENT. THIS EVENT IS CONCLUDED TO BE CAUSED BY USER ERROR AS THE USER/CAREGIVER HAD NOT FOLLOWED HANDICARE'S INSTRUCTIONS. HANDICARE WILL CONTINUE TO MONITOR THIS TYPE OF EVENT.

    Description of Event or Problem · 0

    A MALE RESIDENT WAS BEING TRANSFERRED FROM THE BED TO A SHOWER CHAIR USING THE HANDICARE MINILIFT 160. AS HE WAS BEING LIFTED TO TRANSFER HIM TO THE SHOWER CHAIR, HIS FEET SLIPPED OFF THE FOOTPLATE OF THE LIFT. THE CARE STAFF TRANSFERRED HIM BACK TO HIS BED. THE RESIDENT BRUISED HIS KNEES DURING THE PROCESS. HE WAS NEVER TAKEN TO THE HOSPITAL, BUT LOOKED OVER BY AMBULANCE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155125 MINILIFT160 PATIENT LIFT FSA HANDICARE AB 60300012

    Patients

    Seq Age Sex Outcome Treatment
    1 Male