BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 2223509 · Received July 13, 2011

    Report

    Report Number
    9611530-2011-00054
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFR ARJO HOSP EQUIPMENT (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MFG AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED (B)(4) (UNDER REGISTRATION #9617021). AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSP EQUIPMENT (B)(4) AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #9611530. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    TWO CAREAIDS WERE TRANSFERRING THE RESIDENT OFF OF THE TOILET USING A MARISA LIFT. THE RESIDENT WAS ROUGHLY 1 METER OFF OF THE GROUND WHEN THE ARM OF THE HANGER BAR FELL FROM THE LIFT. THE RESIDENT FELL TO THE FLOOR WITH THE HANGER BAR ON TOP OF HER. UPON INSPECTION THE STAFF NOTICED THE PIN HOLDING THE HANGER BAR WAS MISSING. THE RESIDENT SUFFERED A SMALL CUT ON THE LIP WITH SOME LIGHT BLEEDING AND WAS TREATED ON-SITE. THEY WERE SENT TO THE HOSP THE NEXT DAY AND DISCHARGED WITH NO OTHER INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA PASSIVE FLOOR LIFT FSA ARJO MED AB LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O