BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAEE LIFTS

    MDR report key: 5973292 · Received September 23, 2016

    Report

    Report Number
    3009481053-2016-00008
    Event Type
    Malfunction
    Date Received
    September 23, 2016
    Date of Event
    August 16, 2016
    Report Date
    September 23, 2016
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PERFORMED BY HANDICARE AB SHOWS THAT THE RISK FOR PERSONAL DAMAGE CAUSED BY WRONG ASSEMBLY OF LEG STRUTS IS VERY LOW. IF EXPOSED TO SEVERE USE, THE LEG STRUTS MAY FRACTURE AT MOST, WHICH WOULD CAUSE THE MOBILE LIFT TO COME TO A HALT IN ITS MOVEMENT. IF A PATIENT IS ATTACHED TO THE MOBILE LIFT AT THIS TIME, HE/SHE WOULD ALSO STOP MOVING WHILE STAYING ATTACHED TO THE MOBILE LIFT. THE PATIENT COULD THEREAFTER BE SAFELY REMOVED FROM THE MOBILE LIFT BY HEALTHCARE PROFESSIONALS OPERATING THE MOBILE LIFT. THE ROOT CAUSE OF THE DEVICE DEFECT IS THAT THE SUPPLIER HAD NOT PROPERLY FOLLOWED HANDICARE AB'S INSTRUCTIONS AND SPECIFICATIONS DURING DEVICE ASSEMBLY. ALL AFFECTED DEVICES ARE TO BE IDENTIFIED. THE LOCAL DISTRIBUTORS WILL REQUEST THE AFFECTED CUSTOMERS TO INSPECT AND TO CORRECT THE AFFECTED DEVICES AS ACCORDING TO INSTRUCTIONS PROVIDED BY HANDICARE AB. NECESSARY SPARE PARTS WILL BE PROVIDED TO THE CUSTOMERS AS WELL.

    Description of Event or Problem · 1

    THE DEVICE DEFECT WAS DETECTED BY A LOCAL DISTRIBUTOR IN (B)(4). IT WAS DISCOVERED THAT THE RIGHT LEG STRUT HAD SWITCHED POSITION WITH THE LEFT LEG STRUT, DURING ASSEMBLY ON MANUFACTURING STAGE, ON TWO EVA MOBILE LIFTS. AS THE RIGHT LEG STRUT AND THE LEFT LEG STRUT HAVE DIFFERENT LENGTHS, THE WRONG ASSEMBLY MAY IMPAIR THE FUNCTION OF THE MOBILE LIFT. THE WRONGLY ASSEMBLED STRUTS STARTED BENDING DURING THE EVENT. NO PATIENT WAS INJURED DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624650 EVAEE LIFTS LIFT, PATIENT, NON-AC-POWERED FSA HANDICARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1