BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARJO POWERED AMBULIFT

    MDR report key: 36984 · Received August 28, 1996

    Report

    Report Number
    1922538-1996-00082
    Event Type
    Other
    Date Received
    August 28, 1996
    Date of Event
    August 19, 1996
    Report Date
    August 28, 1996
    Manufacturer
    ARJO MANUFACTURING CO.
    Product Code
    FSA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A CLOSING OUT REPORT BY THE FOREIGN REPORTER'S INVESTIGATOR. INVESTIGATION: THE LIFT WAS EXAMINED BUT NO FAULTS COULD BE FOUND. THIS LIFT HAS BEEN USED IN THE SAME ROOM WITH A HILO BATH MANY TIMES BEFORE. OBSERVATIONS: THE INVESTIGATOR HAS OFFERED A POSSIBLE EXPLANATION OF EVENTS - THE JIB WAS LOWERED TOO FAR, THE CHAIR TOUCHED THE BOTTOM OF THE BATH AND MOVED AWAY FROM THE JIB LOCATION. WHEN THE LIFT WAS RAISED THE CHAIR WAS NOT LOCATED PROPERLY ON THE JIB AND THE MOVEMENT OF THE CHAIR RE-ALIGNMENT ITS SELF. FACILITY AGREED THIS WAS POSSIBLE. CONCLUSIONS: USER ERROR. HOIST LOWERED TO FAR. CORRECTIVE ACTION: HOSIT HAS BEEN PUT BACK INTO SERVICE, AND STAFF NOT UNDERSTANDS THE PROBLEMS IT THE HOIST IS LOWERED TOO FAR.

    Description of Event or Problem · 1

    THE CHAIR TIPPED AS STAFF WAS LOWERING A FEMALE PT INTO THE BATH. SHE WAS MOBILE ENOUGH TO GET OFF THE CHAIR. NO INJURY TO PT OR STAFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other