BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLERO

    MDR report key: 3234046 · Received July 11, 2013

    Report

    Report Number
    1419652-2013-00178
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMERS STATEMENT: "WHEEL FELL OFF LIFT". ACCORDING TO THE CUSTOMER DESCRIPTION THERE WAS NO PT INVOLVED AND: "THIS EQUIPMENT WAS VOLUNTARILY TAGGED OUT FOR SVC BY THE CUSTOMER AND NOT USED WITH PTS; IT IS UNLIKELY THERE WAS ANY POTENTIAL FOR INJURY." REF #9611530-2013-00070.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319681 BOLERO FSA ARJO HOSPITAL EQUIPMENT AB CEB6003-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other