BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING XL

    MDR report key: 20334101 · Received September 30, 2024

    Report

    Report Number
    8030916-2024-00065
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 30, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    UDI-DI
    00887761981850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INSPECTION, THE TECHNICIAN FOUND THAT THE EMERGENCY STOP SWITCH HAD DETACHED FROM THE BUTTON. 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. THE VIKING¿ L / XL MOBILE LIFT INSTRUCTIONS FOR USE (7EN137108) STATES THE FOLLOWING UNDER INSPECTION AND MAINTENANCE: 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. ¿ CHECK TO MAKE SURE THAT THE EMERGENCY LOWERING (BOTH ELECTRICAL AND MECHANICAL) WORKS. A PM SEARCH WAS PERFORMED ON THIS SERIAL NUMBER RESULTING IN NO PM RECORDS FOUND FOR THIS SERIAL NUMBER. IT IS UNKNOWN IF THE FACILITY PERFORMS THEIR OWN MAINTENANCE. THE TECHNICIAN REATTACHED THE SWITCH TO RESOLVE THE ISSUE AND THE DEVICE WAS FUNCTIONING AS INTENDED. ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE EMERGENCY STOP BUTTON BECAME NON FUNCTIONAL DURING USE IT COULD LEAD TO SERIOUS INJURY OR DEATH. THEREFORE BAXTER IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE EMERGENCY STOP WAS NOT FUNCTIONING CORRECTLY. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS INCIDENT WAS CAPTURED UNDER COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054049 VIKING XL LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 2040043 00887761981850

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown