BEUDAMED
    FDA Adverse Event Other Summary report: N

    SABINA

    MDR report key: 788477 · Received November 16, 2006

    Report

    Report Number
    1225750-2006-00029
    Event Type
    Other
    Date Received
    November 16, 2006
    Date of Event
    September 1, 2005
    Report Date
    October 19, 2006
    Manufacturer
    LIKO, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE CALL RECEIVED AT LIKO INC 10/19/2006 IN WHICH THE FACILITY ADMINISTRATOR MADE MENTION OF AN INCIDENT WITH A SABINA PATIENT LIFT HAD OCCURRED IN SEPTEMBER 2005. LIKO INC HAD NOT BEEN NOTIFIED OF THE INCIDENT PRIOR TO THIS DATE. FOLLOW UP PHONE CALL TO THE FACILITY ADMINISTRATOR BY LOCAL LIKO DISTRIBUTOR, REVEALED THAT THE FACILITIES INTERNAL INVESTIGASTION AT THE TIME OF THE INCIDENT, CONCLUDED THAT THE INCIDENT WAS CAUSED BY HUMAN ERROR, NOT LIFT MALFUNCTON, AS OPERATORS DID NOT HAVE BELT HOOKED UP PROPERLY. THE LIFT WAS INSPECTED BY FACILITY STAFF AND RETURNED TO SERVICE. REMEDIAL STAFF TRAINING ON THE PROPER USE OF LIKO EQUIPMENT HAS BEEN OFFERED TO THE FACILITY BY DISTRIBUTOR.

    Description of Event or Problem · 1

    10/19/2006, REPORT RECEIVED BY LIKO REPRESENTATIVE OF AN INCIDENT AT A FACILITY IN SEPTEMBER 2005, DURING WHICH A RESIDENT FELL AND SUFFERED A BROKEN HIP, WHILE BEING TRANSFERRED IN A SABINA LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABINA PATIENT LIFT/HOIST FSA LIKO, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other