BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA

    MDR report key: 2922532 · Received January 9, 2013

    Report

    Report Number
    9681684-2012-00102
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR ARJOHUNTLEIGH MAGOG INC. ON BEHALF OF THE IMPORTER (B)(6). PLEASE NOTE THAT THIS PRODUCT IS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE (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 ARJOHUNTLEIGH MAGOG AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLOOR LIFT WAS USED AND WHILE THE DEVICE HAD JUST BEGUN TO ENCOUNTER THE RESIDENT'S LOAD, THE JIB SNAPPED. THE RESIDENT WAS UNHARMED, AS FOR THE CAREGIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10791 OPERA MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO MED AB LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1