BEUDAMED
    FDA Adverse Event Summary report: N

    ALENTI

    MDR report key: 3150003 · Received May 31, 2013

    Report

    Report Number
    1419652-2013-00139
    Date Received
    May 31, 2013
    Date of Event
    April 28, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DETAILS INITIALLY REPORTED BY THE ARJOHUNTLEIGH REPRESENTATIVE: 'IT HAS BEEN REPORTED THAT THE HOIST TOPPLED OVER WITH A PATIENT ON IT.' ADDITIONAL INFORMATION WAS PROVIDED: "PATIENT HAD FINISHED HAVING A BATH USING THE ALENTI, SHE WAS THEN RAISED OUT OF THE BATH AND POSITIONED ADJACENT TO THE BATH, TO BE DRIED, AND TO HAVE DRESSINGS APPLIED TO HER LEGS. THE CHAIR AT THIS TIME, WAS AT ITS HIGHEST POSITION (95CM FROM FLOOR), AND THE BRAKES WERE ON. DURING THIS, ANOTHER RESIDENT ENTERED THE BATHROOM TO USE THE TOILET, PATIENT BECAME VERY DISTURBED AND STARTED TO MOVE AROUND ERRATICALLY ON THE CHAIR. AS A RESULT OF THIS, THE CHAIR TOPPLED OVER. PATIENT FELL TO THE FLOOR WITH THE CHAIR, SHE DID NOT FALL OUT OF THE CHAIR, AS THE CHAIR ARMS STOPPED THIS FROM HAPPENING. THERE WAS NO SAFETY BELT ON THE HOIST". THE PATIENT INJURES WERE DESCRIBED AS: BRUISING ON THE HIP. PATIENT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240217 ALENTI HYGIENE AND POOL LIFTERS FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other