BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARINA

    MDR report key: 7820967 · Received August 27, 2018

    Report

    Report Number
    3009481053-2018-00036
    Event Type
    Death
    Date Received
    August 27, 2018
    Date of Event
    June 20, 2018
    Report Date
    August 27, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE PROBLEM FOUND, THE USER MISS HANDLED THE SLING (NOT MANUFCATURED BY HANDICARE) DURING THE INCIDENT.

    Description of Event or Problem · 1

    PATIENT FELL OFF FROM THE 4 POINTS HIGH BACK SLING SHEET DURING LIFT BY CARINA 350MM WHILE TRANSFERRING FROM BED (AT HIGHEST POSITION) TO WHEEL CHAIR. PATIENT DECEASED IN HITTING HER HEAD TO THE FLOOR. ONE OF THE SLING STRAP (LEFT SIDE LEG) WAS NOT HOOKED ON THE SLING BAR. ACCORDING TO POLICE INVESTIGATION, THE ACCIDENT OCCURRED UNDER THE MISS HANDLING BY CAREGIVER. CAREGIVER ADMITTED. NO DAMAGES TO THE PATIENT LIFT OR SLING SHEET WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659974 CARINA PATIENT LIFTS FSA HANDICARE AB 60600012

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death