BEUDAMED
    FDA Adverse Event Death Summary report: N

    V4

    MDR report key: 10758143 · Received October 29, 2020

    Report

    Report Number
    1419652-2020-00056
    Event Type
    Death
    Date Received
    October 29, 2020
    Date of Event
    October 1, 2020
    Report Date
    October 29, 2020
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJO RECEIVED INFORMATION FROM DOCTOR, (B)(6) FACILITY REPRESENTATIVE ABOUT AN INCIDENT WITH ARJO V4 CEILING LIFT INVOLVEMENT. A FEMALE RESIDENT SUFFERING SCHIZOPHRENIA WALKED INTO ANOTHER ROOM DURING THE NIGHT. SHE BROUGHT A CHAIR FROM THE HALL, CLIMBED ONTO THE BED NEAR SLEEPING RESIDENT, TIED A KERCHIEF AROUND 2-POINT SPREADER BAR AND STEPPED OFF THE BED. IN EFFECT, THE RESIDENT DECEASED. ARJO REPRESENTATIVE WENT ON SITE TO GATHER MORE INFORMATION AND INSPECT THE DEVICE. V4 CEILING LIFT WAS IN GOOD CONDITION. THE ONLY MALFUNCTION WAS EMERGENCY STOP CORD, WHICH HAD TO BE CUT BY THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219654 V4 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. 9100001

    Patients

    Seq Age Sex Outcome Treatment
    1 Death