BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXILIFT

    MDR report key: 2910297 · Received November 15, 2012

    Report

    Report Number
    9611530-2012-00204
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    January 10, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJO HOSPITAL EQUIPMENT (B)(4). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED, PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE ARJO MED AB LTD. AS OF 06/15/2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE ON 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. ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    AS STATED BY THE CUSTOMER (B)(6) 2012: REPLACEMENT OF BROKEN PARTS ON MAXILIFT. REPLACED SPIRAL PIN, GUIDE PIECES AND SIDE STRIPE ON RIGHT SIDE. TESTED LIFT, LIFT IS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT PASSIVE FLOOR LIFTS FSA ARJO MED AB LTD 2120XX

    Patients

    Seq Age Sex Outcome Treatment
    1