BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RISEATLAS 450T

    MDR report key: 8048103 · Received November 7, 2018

    Report

    Report Number
    3009481053-2018-00046
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 24, 2018
    Report Date
    May 6, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A CEILING LIFT STOPPED WORKING WHEN IN USE. THIS OCCURRED TWICE WITH THE SAME LIFT. THE PATIENT COULD NOT CONTROL THE LIFT WITH THE HAND CONTROLLER AND HAD TO USE THE EMERGENCY STRAP TO GET DOWN. THE FACT THAT THE EMERGENCY STRAP WORKED MEANS THAT THE MACHINE HAS POWER BECAUSE THE SWITCH IS ELECTRICAL, MAKING THE CASE FOR A FAULTY BATTERY UNLIKELY. THE MOST LIKELY CAUSE IS THAT THE HAND CONTROLS HAS BEEN YANKED OR PULLED REPEATEDLY OVER TIME AND THAT THE HAND CONTROL JACK ULTIMATELY LOST THE ELECTRICAL CONNECTION IN THE SOCKET. REINSERTING THE HAND CONTROL JACK WOULD MOST LIKELY SOLVED THE PROBLEM. HANDICARE BELIVES THAT THERE WAS NOTHING WRONG WITH THE CONTROLLER, UNFORTUNATELY THE CONTROLLER WAS LOST DUE TO THEFT, SO THIS CANNOT BE VERIFIED. CORRECTIVE ACTION: A O-RING IS BEING ADDED ONTO THE HAND CONTROL JACK, THIS SHOULD PREVENT IT FROM ACCIDENTALLY EJECTING FROM THE SOCKET.

    Description of Event or Problem · 0

    THE USER CAME UP A BIT IN THE ROOF LIFTER, IT STOPPED WORKING. THE USER ENDED UP ON THE FLOOR AND CALLED THE RESCUE SERVICE TO GET HELP GETTING UP, THE USER SAT IN THE LIFT AND WHEN HE WAS GOING BACK TO BED AFTER THE MORNING COMMAND, THE LIFT GOT STUCK AND IT COULD NOT BE LOWERED. THE HOME SERVICE GOT DRESSED IN THE WHEELCHAIR. THE SAME CEILING LIFT UNIT MALFUNCTIONED ON TWO OCCASIONS DURING USE BY THE SAME CUSTOMER. EVENT 1 CEILING LIFT UNIT STOPPED FUNCTIONING DURING PATIENT TRANSFER. USER ENDED UP ON THE FLOOR AND HAD TO CALL FOR ASSISTANCE TO GET UP. EVENT 2 CEILING LIFT UNIT STOPPED MOVING DURING PATIENT TRANSFER. THE PATIENT WAS UNABLE TO MOVE IN ANY DIRECTION AND NEEDED ASSISTANCE FROM CAREGIVERS TO BE SEATED IN THE WHEELCHAIR.

    Description of Event or Problem · 1

    THE USER CAME UP A BIT IN THE ROOF LIFTER, IT STOPPED WORKING. THE USER ENDED UP ON THE FLOOR AND CALLED THE RESCUE SERVICE TO GET HELP GETTING UP, THE USER SAT IN THE LIFT AND WHEN HE WAS GOING BACK TO BED AFTER THE MORNING COMMAND, THE LIFT GOT STUCK AND IT COULD NOT BE LOWERED. THE HOME SERVICE GOT DRESSED IN THE WHEELCHAIR. THE SAME CEILING LIFT UNIT MALFUNCTIONED ON TWO OCCASIONS DURING USE BY THE SAME CUSTOMER. EVENT 1 - CEILING LIFT UNIT STOPPED FUNCTIONING DURING PATIENT TRANSFER. USER ENDED UP ON THE FLOOR AND HAD TO CALL FOR ASSISTANCE TO GET UP. EVENT 2 - CEILING LIFT UNIT STOPPED MOVING DURING PATIENT TRANSFER. THE PATIENT WAS UNABLE TO MOVE IN ANY DIRECTION AND NEEDED ASSISTANCE FROM CAREGIVERS TO BE SEATED IN THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888778 RISEATLAS 450T CEILING LIFT FSA HANDICARE AB 450T 763724

    Patients

    Seq Age Sex Outcome Treatment
    1