BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIKORALL

    MDR report key: 1894975 · Received November 4, 2010

    Report

    Report Number
    8030916-2010-00029
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 24, 2009
    Report Date
    October 19, 2010
    Manufacturer
    LIKO AB
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LIFT HAS RETURNED TO MANUFACTURER FOR INVESTIGATION. IT WAS FOUND TO BE IN GOOD WORKING CONDITION. THE ONLY PROBLEM FOUND WAS THAT THE CONNECTION FROM THE CORD TO THE HAND CONTROL HAD BEEN PULLED APART, POSSIBLY BY FORCE. NO FAILURE COULD BE FOUND ON THE LIFT THAT COULD HAVE CAUSED THE ALLEGED INCIDENT. THE CUSTOMER HAS BEEN CONTACTED SEVERAL TIMES, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TRANSFERRED FROM THE BED TO THE BATH. NO EVIDENCE OF PROBLEMS WITH THE LIFT. AFTER THE BATH, THE PATIENT WAS MOVED BACK TO THE BED TO GET IN HIS CLOTHES. WHEN HE WAS POSITIONED ABOVE THE BED, THE LIFT MOTOR STOPPED. THE CAREGIVER CONTINUED WITH THE TRANSFER. A LOUD NOISE WAS HEARD AND THE PATIENT FELL APPROX 2" ONTO HIS BED. NO INJURIES WERE ALLEGED. THE CORD TO THE HAND CONTROL WAS COMPLETELY BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIKORALL AC POWERED PATIENT LIFT FNG LIKO AB LIKORALL 240 R2R

    Patients

    Seq Age Sex Outcome Treatment
    1