BEUDAMED
    FDA Adverse Event Summary report: N

    MARISA

    MDR report key: 3140276 · Received May 24, 2013

    Report

    Report Number
    1419652-2013-00136
    Date Received
    May 24, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE OCCURRED IN A MARISA, A LIFTER FOR ASSISTED LIFTING, AND IT WAS REPORTED FROM THE CUSTOMER; "5 CNAS ALONG WITH NURSE, WERE TRANSFERRING RESIDENT WITH A MARISA FROM A PVC SHOWER BED TO A CAMTEC ELECTRIC MODEL 635/835 CARE CHAIR (BARIATRIC). UNABLE TO LOWER RESIDENT DIRECTLY OVER CHAIR DUE TO THE MARISA BOOM NOT EXTENDING OUT FAR ENOUGH WHILE RESIDENT IS UNABLE TO BE IN SITTING POSITION. CAREGIVERS ATTEMPTED TO PUSH/PULL RESIDENT IN SLING OVER CHAIR AND LOWER CAUSING LIFT TO LEAN AND TIP OVER." REF # 1419652-2013-00136.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232355 MARISA PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD KGA0200

    Patients

    Seq Age Sex Outcome Treatment
    1