BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FGA 450

    MDR report key: 6674591 · Received June 28, 2017

    Report

    Report Number
    3007802293-2017-00093
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 1, 2017
    Report Date
    June 28, 2017
    Manufacturer
    PRISM MEDICAL
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE FACILITY SHARED THE RESIDENT WAS BEING TRANSFERRED WITH ASSISTANCE OF TWO PEOPLE FROM HER BED TO HER WHEEL CHAIR USING A FGA 450 LIFT WITH A QUICK RELEASE EASY SWIVEL CARRY BAR AND A SIZE SMALL UNIVERSAL SLING. AS THE LIFT WAS BEING MOVED TOWARDS THE CHAIR THE SLING MIDDLE LOOP MIGRATED OFF THE LIFT HOOK ON THE RIGHT SIDE. THE RESIDENT'S UPPER BODY SLID TO THE RIGHT, THROUGH THE SIDE OF SLING, BETWEEN THE TWO DISTAL LOOPS. SHE FELL ONTO THE FLOOR. THE FACILITY REMOVED THE LIFT FROM SERVICE TO INVESTIGATE. THE RESIDENT RECEIVED MEDICAL TREATMENT. SHE HAD A HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456694 FGA 450 FGA 450 LIFT FSA PRISM MEDICAL 280411

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization