BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALENTI

    MDR report key: 3688117 · Received March 12, 2014

    Report

    Report Number
    3007420694-2014-00024
    Event Type
    Death
    Date Received
    March 12, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER ARJUHUNTLEIGH INC ((B)(4)). WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR ALENTI DEVICE WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (SAFETY BELTS NOT USED). THE DEVICE WAS PUT THROUGH A FUNCTION TEST BY THE ARJOHUNTLEIGH REPRESENTATIVE THAT VISITED THE SITE AND WAS FOUND TO BE IN FULL WORKING ORDER. A VISUAL CHECK REVEALED SOME SCRATCHES, BRAKES HAD VERY SLIGHT WEAR. FROM THIS IT APPEARS THE DEVICE WAS UP TO SPECIFICATION AT THE TIME OF THE EVENT; HOWEVER IT IS ALSO NOTED THAT THE SAFETY BELT, WHICH IS NEEDED FOR EACH USE AND AS AN ACCESSORY IS A PART OF THE DEVICE, WAS PRESENT DURING THE COMPANY REPRESENTATIVE INSPECTION BUT IT WAS SAID THAT IT WAS NOT USED DURING THE INCIDENT. IT IS CLEARLY INDICATED IN THE EVENT DESCRIPTION THAT THE REASON FOR THE PERSON ON THE DEVICE TO FALL, WAS THE FACT THAT THE RESIDENT WAS WITHOUT SAFETY BELT, WITH THE SAFETY ARM LIFTED AND LEFT FOR A WHILE UNATTENDED AS THE CAREGIVER TURNED OVER FOR A TOWEL. THE ALENTI DEVICE IS INTENDED FOR USE WITH PATIENTS WHO ARE ABLE TO SIT IN UPRIGHT POSITION. THE INCIDENT DESCRIPTION SHOWS THAT THE PATIENT LEARNED FORWARD WHAT CAN BE A RESULT OF PATIENT NOT BEING SUITABLE FOR USE WITH THIS DEVICE AND THAT THE PATIENT ASSESSMENT WAS NOT DONE PROPERLY OR CONDITION OF PATIENT CAME WORSE AFTER HE BATHING. SEE SCANNED PAGE. NOTE THAT THE EVENT DESCRIPTION CLEARLY INDICATES THE BELT WAS NOT USED ALTHOUGH IT IS REQUIRED BY THE DEVICE LABELING. THEREFORE AS STATED BY THE CUSTOMER FACILITY ALSO THERE APPEARS TO HAVE BEEN NO DEFICIENCY WITH THE DEVICE BUT A NUMBER OF USE ERRORS CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO EVALUATE THE PERSON BEFORE USE WITH ALENTI DEVICE AND NOT USING THE SAFETY BELTS. THE DEVICE WAS DIRECTLY INVOLVED IN THE EVENT AND WAS USED FOR TREATMENT AT THE TIME, IT WAS OPERATING TO SPECIFICATION. FROM THIS WE CONCLUDE THAT THIS UNFORTUNATE EVENT WAS CAUSED AS A RESULT OF STAFF INCORRECTLY OR NOT FOLLOWING THE PATIENT HANDLING PROCEDURE AS INDICATED IN THE INSTRUCTIONS FOR USE OF THE DEVICE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149072 ALENTI FSA ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1