BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLIFT

    MDR report key: 1000842 · Received February 21, 2008

    Report

    Report Number
    9617021-2008-00008
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI) CLEARLY INDICATE THAT THE DOCUMENT SHOULD BE READ BEFORE THE PRODUCT IS USED. THE MANUAL INCLUDES A WARNING WHICH STATES. "FAILURE TO FOLLOW THESE INSTRUCTIONS MAY RESULT IN INJURY TO YOURSELF OR TO OTHERS." THE SECTION TITLED USING YOUR AUTOLIFT GOES INTO DETAIL, WARNING" [...] ROTATE THE WINDING HANDLE AND/OR OPERATE THE ROTATION LOCK RELEASE LEVER TO POSITION THE SEAT OUTSIDE THE BATH AND AT A SUITABLE HEIGHT FOR THE RESIDENT TO TRANSFER SAFELY ONTO THE SEAT." A DIAGRAM IS PROVIDED TO SUPPORT THIS INSTRUCTION AND WARNING. THE LIFT'S OPERATOR DOES NOT APPEAR TO HAVE RECEIVED ANY TRAINING ON THE PRODUCT, AS NO TRAINING DATE COULD BE GIVEN. BASED ON THE INFO RECEIVED, THE MFR CONCLUDES THE EVENT WAS CAUSED BY A USE ERROR OF THE DEVICE, BROUGHT ABOUT BY INSUFFICIENT KNOWLEDGE OF THE OPI. THERE APPEAR TO BE NO RELEVANT REMEDIAL ACTIONS REQUIRED TOWARDS THE PRODUCT. HOWEVER, THE MFR WILL CONTINUE MONITORING COMPLAINT TRENDING FOR POSSIBLE FUTURE ACTIONS. THE MFR RECOMMENDS THE LIFT OPERATORS ON-SITE BE TRAINED ON THE OPI BEFORE RESUMING USE OF THE LIFT.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE BATH HAD BEEN COMPLETED, SO THE CAREGIVER RAISED THE RESIDENT IN THE LIFT AND MOVED HER AROUND TO EXIT THE BATH. IT IS REPORTED THE LIFT WAS NOT ABLE TO BE LOCKED INTO POSITION IN A SUITABLE AREA OUTSIDE OF THE TUB, SO IT IS REPORTEDLY LEFT IN MID-POSITION. THE PT HOLDS ON TO A TOILET COMMODE TO STEADY HERSELF. IT WAS AT THIS POINT THAT THE PT SLIPPED, WITH THE LIFTER SWINGING IN THE OPPOSITE DIRECTION. SHE FELL OUT OF THE SEAT; NO INJURIES OTHER THAN MINOR BRUISING WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOLIFT PATIENT LIFT FNG ARJO MED AB LTD. BBXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1