BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI WITH SCALE

    MDR report key: 1001858 · Received February 25, 2008

    Report

    Report Number
    9611530-2008-00006
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    October 19, 2007
    Report Date
    February 25, 2008
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ARJO INVESTIGATOR EXAMINED THE DEVICE AND FOUND ALL FUNCTIONS WORKING. THERE WERE 47 INCHES BETWEEN THE TUB AND A PEDESTAL TUB ON THE LEFT, 62 INCHES TO THE RIGHT, 101 INCHES FROM THE END OF THE TUB TO THE WALL. THE FLOOR AROUND THE DRAIN AND AT THE POINT FOR TRANSFERRING IN AND OUT OF THE TUB WAS WET. THE SEAT BELT HAD NOT BEEN CORRECTLY POSITIONED. A VELCRO STRAP HAD BEEN BOLTED TO THE BATTERY THEN WRAPPED AROUND THE PILLAR. A CASTOR HAS BEEN RETURNED TO MFG FOR EVAL, BUT IT IS NOT CLEAR AS TO WHETHER IT IS THE CASTOR FROM THE INCIDENT OR NOT. THE MAINTENANCE PERSONNEL INDICATED THAT THE THREADED POST WAS INTACT AND THE BEARING SEEMED STICKY. THE CASTOR REPLACED IN THE PICTURES FROM THE SITE IS THE FRONT SAME SIDE AS THE BACK REST. THERE IS MINIMAL SERVICE HISTORY FOR THE DEVICE. ON JULY 6, 2007, THERE WAS A REQUEST TO TIGHTEN THE BOLTS ON THE BASE. IN 2007, REGULAR MAINTENANCE ACCORDING TO THE FACILITY'S INTERNAL PROGRAM WAS DONE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS, AFTER THE BATH, THE CAREGIVER WAS MOVING THE LIFT OUT OF THE TUB FROM THE LEFT SIDE OF THE TUB. SHE WAS PULLING THE LIFT BACK AND TURNING AT THE SAME TIME OVER THE FLOOR DRAIN AREA. THE CASTOR OF THE LIFT FELL OFF, CAUSING THE LIFT TO TILT. THE RESIDENT FELL TO THE SIDE, HITTING HER RIBS AGAINST THE SIDE SUPPORT AND HITTING HER HEAD ON THE LIFT. THE CAREGIVER CALLED FOR HELP; ANOTHER CAREGIVER CAME AND ASSISTED WITH GETTING THE RESIDENT OFF THE LIFT. IT IS UNKNOWN WHETHER THE RESIDENT WAS WEARING THE SEAT BELT. THE RESIDENT SUSTAINED BRUISED RIBS BUT NO FURTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI WITH SCALE LIFT HYGIENE CHAIR FSA ARJO HOSPITAL EQUIPMENT AB CDBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1