BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 9000

    MDR report key: 13769052 · Received March 15, 2022

    Report

    Report Number
    8030916-2022-00013
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 15, 2022
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS FOUND THAT THE ACCOUNT HAD A VIKING XL WITH A BROKEN EMERGENCY BUTTON. THE MOBILE LIFT COULD BE OPERATED WHEN THE EMERGENCY STOP BUTTON WAS ENGAGED. A TECHNICIAN INSPECTED THE LIFT AND FOUND THAT THE EMERGENCY STOP BUTTON WAS DISCONNECTED. THE EMERGENCY STOP BUTTON WAS RECONNECTED. THE LIFT WAS TESTED AND FUNCTIONED AS DESIGNED. VIKING XL MOBILE LIFT IS A VERSATILE LIFT MODEL INTENDED MAINLY FOR USE IN HEALTH CARE, INTENSIVE CARE AND REHABILITATION. VIKING XL MOBILE LIFT IS INTENDED FOR HEAVIER PATIENTS. THE MODEL IS AN EXCELLENT AID IN DAILY TRANSFERS OF ADULTS AND BARIATRICS, FOR INSTANCE, LIFTING TO AND FROM WHEEL CHAIR, BED, TOILET AND FLOOR. A VIKING MOBILE LIFT EQUIPPED WITH THE VIKING ARMREST ACCESSORY CAN BE USED FOR GAIT TRAINING. HORIZONTAL LIFTING CAN ALSO BE PERFORMED IN COMBINATION WITH A RECOMMENDED LIKO STRETCHER ACCESSORY. ACCORDING TO HILLROM¿S PERIODIC INSPECTION FOR LIKO MOBILE LIFTS (3EN371001 REV. 4), THE EMERGENCY STOP FUNCTION MUST BE CHECKED AT LEAST ONCE EVERY YEAR. IN THE DOCUMENT IT IS STATED UNDER SECTION 10: "PRESS THE EMERGENCY STOP BUTTON. WITH THE EMERGENCY STOP PRESSED IN, VERIFY THE LIFT DOES NOT OPERATE WITH THE HAND CONTROL BUTTONS. TURN THE RED EMERGENCY BUTTON IN THE DIRECTION OF THE ARROWS. VERIFY THE BUTTON RELEASES FROM THE LOCKED POSITION INTO THE RAISED, OPEN POSITION." ALTHOUGH THE REPORTED EVENT DID NOT RESULT IN A SERIOUS INJURY, THE REPORT OF AN EMERGENCY BUTTON NOT FUNCTIONING DURING PATIENT TRANSFER COULD CONTRIBUTE TO A SERIOUS INJURY OR DEATH, IF THE MALFUNCTION WERE TO RECUR. THEREFORE, HILLROM CONSIDERS THIS COMPLAINT A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT THE EMERGENCY STOP BUTTON WAS NOT WORKING, WHEN IT WAS PRESSED THE MOBILE LIFT CONTINUED TO WORK. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. THERE WAS NO PATIENT OR USER INJURY. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38651 GOLVO 9000 LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 2000045