BEUDAMED
    FDA Adverse Event Other Summary report: N

    AFJO TRIXIE LIFT

    MDR report key: 49824 · Received November 11, 1996

    Report

    Report Number
    1922538-1996-00123
    Event Type
    Other
    Date Received
    November 11, 1996
    Date of Event
    October 22, 1996
    Report Date
    November 11, 1996
    Manufacturer
    ARJO MFG CO.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A CLOSING OUT REPORT FROM THE FOREIGN REPORTER. INVESTIGATION: THE ENVIRONMENT WAS A NEW UNIT WHICH WAS CARPETED. OBSERVATIONS: UPON EXAMINATION OF THE HOIST, IT WAS FOUND THAT THE RIGHT HAND LEG LOCKING CATCH WAS NOT LOCATED. THE INVESTIGATOR PLACED FOOT ON LEG AND RAISED THE JIB BY HAND TO ALLOW CATCH TO ENGAGE. THERE WAS NO FAULT FOUND WITH THE CATCH. CONCLUSIONS: THE INCIDENT WAS A RESULT OF OPERATOR ERROR. CORRECTIVE ACTION: THE INVESTIGATOR SHOWED GENERAL MANAGER HOW TO LOCATE LEG BY RAISING JIB BY HAND KEEPING FOOT ON LEG UNTIL THE CATCH IS LOCATED.

    Description of Event or Problem · 1

    HOIST WAS USED FOR FIRST TIME FOLLOWING COMMISSION, WITH A MALE PT. UPON RAISING THE HOIST TITLED OVER AND ONE CHASSIS LEG WAS FOUND TO BE NOT LOCKED IN POSITION. SINCE THIS THE STAFF HAVE NOT BEEN ABLE TO SAFELY LOCK THIS LEG. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFJO TRIXIE LIFT MOBILE SLING LIFTER FNG ARJO MFG CO. KTB2000-11-US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other