BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 2105304 · Received May 18, 2011

    Report

    Report Number
    9611530-2011-00041
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MFG, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED AB LTD (UNDER REGISTRATION (B)(4)). AS OF (B)(6) 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 HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION # (B)(4). THE FACILITY COULD NOT PRODUCE THE DEVICE THAT WAS BEING USED DURING THE INCIDENT, AND ALSO WAS NOT ABLE TO CONFIRM THE EXACT MODEL. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE A NURSING ASSISTANT WAS TRANSPORTING A RESIDENT FROM A WHEELCHAIR TO THE BED USING AN ARJOHUNTLEIGH LIFT, THE SLING GOT CAUGHT ON THE WHEELCHAIR. WHEN THE NURSING ASSISTANT TRIED TO FREE THE SLING FROM THE WHEELCHAIR, THE CLIP CAME OFF AND THE RESIDENT FELL TO THE FLOOR AND BUMPED HER HEAD. THE RESIDENT WAS TAKEN TO THE HOSPITAL FOR EVAL.

    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 84 YR Hospitalization