BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA

    MDR report key: 2091129 · Received May 11, 2011

    Report

    Report Number
    8030916-2011-00026
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCOUNT WAS ADVISED TO KEEP THE LIFT OUT OF SERVICE UNTIL LIFT WAS REPAIRED. CUSTOMER HAS NOT YET PLACED AN ORDER FOR REPLACEMENT PARTS. NO SERIAL NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    FACILITY ALLEGED THAT THE FOOTPLATE ON A SABINA IS CRACKED. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABINA NON-AC POWERED PATIENT LIFT FSA LIKO AB SABINA II EE

    Patients

    Seq Age Sex Outcome Treatment
    1