BEUDAMED
    FDA Adverse Event Death Summary report: N

    GULDMANN

    MDR report key: 10233956 · Received July 6, 2020

    Report

    Report Number
    3002771221-2020-00001
    Event Type
    Death
    Date Received
    July 6, 2020
    Date of Event
    April 20, 2020
    Report Date
    May 8, 2020
    Manufacturer
    V. GULDMANN A/S
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON PHOTOS/VIDEO MATERIAL SUPPLIED BY THE FACILITY, AND AN IN-HOUSE SIMULATION, EVERY INDICATION POINTS TO AN INCORRECT INSTALLATION BY A 3RD PARTY. ALL RESIDENT ROOMS HAVE NOW BEEN SERVICED.

    Description of Event or Problem · 1

    A RESIDENT WAS TRAVERSED THROUGH THE COMBI-LOCK PART OF THE SYSTEM AND THE CEILING LIFT CAME OUT OF THE RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700126 GULDMANN CEILING LIFT FSA V. GULDMANN A/S 555237 0000045963

    Patients

    Seq Age Sex Outcome Treatment
    1 Death