BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALENTI

    MDR report key: 1660558 · Received April 7, 2010

    Report

    Report Number
    9611530-2010-00018
    Event Type
    Malfunction
    Date Received
    April 7, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION. TRACK WISE ID.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER 2010-(B)(6): A RESIDENT TIPPED OVER AN ALENTI TUB LIFT, IN THE LOWEST SEAT POSITION. THE RESIDENT WAS A LARGER MAN. THE RESIDENT WAS TRYING TO STAND UP ON HIS OWN, AND IS FINE. SALES REP HAS NOT HEARD BACK FROM FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALENTI LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1