BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 200

    MDR report key: 19456985 · Received June 4, 2024

    Report

    Report Number
    8030916-2024-00029
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 4, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIKORALL OVERHEAD LIFT IS A STATIONARY LIFT MOUNTED IN A RAIL SYSTEM. THE RAIL SYSTEM CAN BE BUILT STRAIGHT, WITH OR WITHOUT CURVES, AS A TRAVERSE SYSTEM AND ALSO AS A ROOM-TO-ROOM SYSTEM. LIKORALL OVERHEAD LIFT IS INTENDED FOR USE IN LIFTING AND TRANSFERRING PATIENTS, FOR EXAMPLE, FROM BED TO A WHEELCHAIR, TO OR FROM THE FLOOR, FOR VISITS TO THE TOILET, FOR GAIT, STANDING AND BALANCE TRAINING, WHEN WEIGHING THE PATIENT AND WHEN LIFTING THE PATIENT WITH A STRETCHER. THE CUSTOMER WAS PROVIDED PART # TO ORDER REPLACEMENT HAND CONTROL AND CHARGER CABLE TO RESOLVE THE ISSUE. ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE DEVICE WERE TO HAVE EXPOSED COPPER WIRES SHOWING ON A HIGH VOLTAGE POWER CABLE IT COULD LEAD TO SERIOUS INJURY OR DEATH. HILLROM IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE LIFT¿S CABLE THAT GOES INTO THE CHARGER WAS FRAYED WITH BARE METAL EXPOSED. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY OR DEATH REPORTED FROM THIS ALLEGED INCIDENT. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666517 LIKORALL 200 LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB LIKORALL200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown