BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 4213439 · Received October 22, 2014

    Report

    Report Number
    3007420694-2014-00104
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE: "THE PATIENT HAD JUST BEEN BATHED AND DRIED OFF. THE HOIST HAD BEEN TURNED OUT OF THE BATH 180 DEGREES AND LOWERED DOWN TO A HEIGHT TO ALLOW THE PATIENT TO REST HER FEET FLAT ON THE FLOOR. THE PATIENT WAS SAT ON THE EDGE OF THE SEAT WITH THE ARM REST UP AND THE BRAKES APPLIED, AND HER FEET WERE ON THE FLOOR. THE PATIENT HAD LEANT FORWARD WITH MOST OF HER WEIGHT ON HER FEET, IN ORDER TO SORT OUT HER CATHETER. SHE THEN SAT/LEANT BACK IN THE SEAT, AND AT THIS MOMENT THE HOIST MOVED SIDE WAYS, ALLOWING THE PATIENT TO TUMBLE TO THE FLOOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671881 ALENTI FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. CDB8102-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other