BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL 200

    MDR report key: 19791580 · Received July 22, 2024

    Report

    Report Number
    8030916-2024-00038
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    June 28, 2024
    Report Date
    July 22, 2024
    Manufacturer
    LIKO AB
    Product Code
    FSA
    UDI-DI
    00887761981911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 TECHNICAL CUSTOMER SUPPORT SPECIALIST PROVIDED THE ACCOUNT WITH THE APPROPRIATE PART NUMBER TO RESOLVE. BASED ON THIS INFORMATION, NO ADDITIONAL ACTIONS ARE NECESSARY AT THIS TIME. THE PERIODIC INSPECTION MANUAL FOR OVERHEAD LISTS (3EN191001 REV 2) STATES THE FOLLOWING CAUTION: 5 EMERGENCY STOP: CHECK THAT THE EMERGENCY STOP CORD IS SECURED PROPERLY AND HAS NO DAMAGE. ACTIVATE THE EMERGENCY STOP BUTTON. VERIFY THAT HOLDS AND LOCKS IN THE ACTIVATED POSITION. ALTHOUGH THERE WAS NO ASSOCIATED INJURY REPORTED WITH THIS EVENT, IF THE EMERGENCY STOP BUTTON WERE TO STOP FUNCTIONING DURING PATIENT TRANSFER IT COULD LEAD TO A SERIOUS INJURY OR DEATH, THEREFORE HILLROM/BAXTER IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THE LIFT¿S EMERGENCY STOP WAS NOT ENGAGING. 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
    2221138 LIKORALL 200 LIFT, PATIENT, NON-AC-POWERED FSA LIKO AB 3121001 00887761981911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown