BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING XL

    MDR report key: 16495517 · Received March 7, 2023

    Report

    Report Number
    8030916-2023-00021
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 9, 2023
    Report Date
    March 7, 2023
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN WHO INSPECTED THE LIFT ON SITE COULD NOT REPLICATE THE ALLEGED MALFUNCTION, THEREFORE, IT WAS NOT POSSIBLE TO IDENTIFY WHICH OF THE 4 WHEELS WAS NOT WORKING AS EXPECTED. THE 4 WHEELS WILL BE REPLACED FOR THE CUSTOMER. VIKING L AND XL MOBILE LIFTS ARE TWO VERSATILE LIFT MODELS INTENDED MAINLY FOR USE IN HEALTH CARE, INTENSIVE CARE AND REHABILITATION. VIKING L AND XL MOBILE LIFTS ARE INTENDED FOR HEAVIER PATIENTS. BOTH MODELS ARE EXCELLENT AIDS 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. IN THE INSTRUCTION FOR USE MANUAL FOR VIKING L/XL (7EN137108 REV. 3), IT IS STATED: FOR TROUBLE-FREE USE, CERTAIN DETAILS SHOULD BE CHECKED EACH DAY THE LIFT IS USED: INSPECT THE LIFT AND CHECK TO MAKE SURE THAT THERE IS NO EXTERNAL DAMAGE. CERTAIN ENVIRONMENTS AND CONDITIONS CAN LIMIT THE CORRECT USE OF THE MOBILE LIFTS, INCLUDING: THRESHOLDS, UNLEVEL FLOOR SURFACES, VARIOUS OBSTACLES, AND EXTRA-THICK CARPETS. THESE ENVIRONMENTS AND CONDITIONS CAN CAUSE THE WHEELS OF THE MOBILE LIFT NOT TO ROLL AS INTENDED, POSSIBLE IMBALANCE IN THE MOBILE LIFT, AND INCREASED EXERTION BY THE CAREGIVER. IF YOU ARE UNCERTAIN THAT YOUR CARE ENVIRONMENT FULFILS THE REQUIREMENTS FOR CORRECT USE OF THE MOBILE LIFT, PLEASE CONTACT YOUR HILL-ROM REPRESENTATIVE FOR FURTHER ADVICE AND ASSISTANCE. UNBALANCED LIFTING POSES A TIPPING RISK AND MAY DAMAGE THE LIFT EQUIPMENT! THE PRODUCT HAS AN EXPECTED SERVICE LIFE OF 10 YEARS WHEN CORRECTLY HANDLED, SERVICED AND PERIODICALLY INSPECTED IN ACCORDANCE WITH LIKO¿S INSTRUCTIONS. THIS LIFT WAS MANUFACTURED IN 2012. A SEARCH OF HILLROM PM RECORDS WAS PERFORMED AND THE RECORDS SHOWED THAT THE LAST PM DATE WAS (B)(6) 2022. ALTHOUGH THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE REPORTED EVENT, THE REPORT OF A VIKING XL FRONT WHEEL TIPPING OVER DURING A PATIENT LIFT 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

    THE CUSTOMER ALLEGED OF THE LIFT'S WHEELS WAS GETTING STUCK AND TIPPING OVER DURING TRANSFER. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY, OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139805 VIKING XL LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB P2040003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown