BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARJO AMBULIFT BSQ

    MDR report key: 35878 · Received August 8, 1996

    Report

    Report Number
    1922538-1996-00068
    Event Type
    Other
    Date Received
    August 8, 1996
    Date of Event
    July 19, 1996
    Report Date
    August 7, 1996
    Manufacturer
    ARJO MANUFACTURING CO.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    HOIST WAS RETURNED TO GLOUCESTER FOR EXAMINATION. TWO OF THE THREE SCREWS WHICH RETAIN THE JIB TO THE BSQ ARM WERE BROKEN. THERE WAS NO SIGNS OF THE PAPER JOINT GASKET WHICH SHOULD HAVE BEEN PRESENT. SCREWS WERE REPLACED WITH THE ELECTRO-PHORETIC TYPE & A NEW PAPER GASKET WAS FITTED. THE HOIST HAS NOW BEEN REPAIRED, IT HAS BEEN LOAD TESTED & RETURNED. CAUSE WAS ATTRIBUTED TO MAINTENANCE ERROR ON PART OF USER. USER HAS BEEN INSTRUCTED TO REVIEW THE OPERATIONAL AND MAINTENANCE MANUAL.

    Description of Event or Problem · 1

    PT WAS SITTING ON CHAIR OF HOIST ABOVE BATH. ONE MOMENT SHE WAS LIFTED DOWNWARDS. TWO BOLTS WERE BROKEN SUDDENLY (ON THE LIFTING ARM). PT FELL BACKWARDS IN THE WATER. SMALL BRUISES WERE SUSTAINED, NOT SEVERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARJO AMBULIFT BSQ LIFT FSA ARJO MANUFACTURING CO. ABXXXX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other
    2