BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARISA

    MDR report key: 2647638 · Received July 6, 2012

    Report

    Report Number
    9611530-2012-00100
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 6, 2012
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2010034 BY ARJOHUNTLEIGH, INC. (1419652) ON BEHALF OF THE MFR ARJO MED AB LTD, #9611530. MFR COMPLAINT NUMBER: 83034. 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 (B)(4) (UNDER REGISTRATION #(B)(4)). 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 (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE RESIDENT HAD BEEN PUT INTO A SLING AND WAS THEN LIFTED OUT OF A WHEEL CHAIR BY MARISA HOIST. AT THIS STAGE THE FRONT CASTORS DETACHED FROM THE HOIST AND THE RESIDENT WAS LOWERED BACK DOWN INTO HIS WHEELCHAIR. THE RESIDENT WAS UNINJURED ALTHOUGH ONE OF THE NURSING STAFF HAS STRAINED THEIR ARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1