BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 2105298 · Received May 4, 2011

    Report

    Report Number
    9611530-2011-00036
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT WHILE THIS PRODUCT IS NO LONGER MFG AND 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)(4) 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). FURTHER INFO WILL BE PROVIDED UPON MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    STAFF MEMBERS (B)(6) WERE TRANSFERRING THIS RESIDENT FROM A RECLINING CHAIR TO THE RESIDENT'S BED, UTILIZING A MARISA LIFT AND SLING, WHEN THE LEFT SHOULDER CLIP BECAME UNATTACHED FROM THE LIFTS SPREADER BAR. THE RESIDENT SLOWLY SLID OUT OF THE BACK AREA OF THIS SLING, THE RESIDENT MADE CONTACT WITH THE BACK SIDE OF HER HEAD, STRIKING THE FLAT SURFACE OF A TABLE. RESIDENT SUFFERED BRUISING TO THE BACK OF THEIR HEAD THAT REQUIRED THE ADMINISTRATION OF ICE FOR TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other