BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO 102

    MDR report key: 1244887 · Received November 17, 2008

    Report

    Report Number
    3006252983-2008-00046
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    August 7, 2006
    Report Date
    August 29, 2006
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PURSUANT TO IDENTIFYING A REPORTABLE EVENT INVOLVING UNO 102 PATIENT LIFT, LIKO HAS PERFORMED A RETROSPECTIVE REVIEW ON SIMILAR EVENTS TO DETERMINE REPORTABILITY. THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT WHILE TRANSFERRING A PATIENT FROM BATH, USING AN UNO 102 MOBILE LIFT, THAT THE ACTUATOR BROKE AND THE PATIENT FELL. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNO 102 NON-AC POWERED PATIENT LIFT FSA LIKO AB UNO 102 ES

    Patients

    Seq Age Sex Outcome Treatment
    1