BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 3964764 · Received June 25, 2014

    Report

    Report Number
    9611530-2014-00040
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS INITIALLY REVIEWED AND ASSESSED AS A NON-REPORTABLE COMPLAINT, BASED ON THE INITIAL EVALUATION PERFORMED. INVESTIGATION PERFORMED FOR A SUBSEQUENT SIMILAR EVENT REVEALED THIS COMPLAINT SHOULD HAVE BEEN REPORTED, THEREFORE, IT IS BEING REPORTED RETROSPECTIVELY. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING SIMILAR EVENTS FOR MAXI MOVE WE HAVE FOUND A LOW NUMBER OF OTHER SIMILAR CASES WHERE SPREADER BAR CAME OFF - DUE TO A PROBLEM RELATED WITH PINS. WE HAVEN'T BEEN ABLE TO ESTABLISH THAT THERE IS A COMPLAINT TREND CONCERNING ABOVE REPORTABLE EVENTS. PLEASE NOTE THAT ARJOHUNTLEIGH MANUFACTURED ABOUT (B)(4) MAXI MOVE LIFTS TO DATE WHICH ARE MEANT TO BE USED MULTIPLE TIMES A DAY IN THE MARKET. THE DEVICE WAS INSPECTED BY AN ARJOHUNTLEIGH REPRESENTATIVE AT THE CUSTOMER SITE AND FOUND TO BE OUT OF SPECIFICATION. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM THE INFO REC'D NO INJURY OCCURRED TO THE PATIENT OR CAREGIVER AS A RESULT OF THIS INCIDENT. THE DEVICE INVOLVED IN THIS COMPLAINT WAS INCLUDED ON LIST OF AFFECTED UNITS FOR (B)(4) WHERE RISK OF SPREADER BAR DETACHMENT WAS RE-EVALUATED AND WHERE WAS STATED THAT FOR A DISLOCATION TO OCCUR, THE LOCK AND LOAD HANGER WILL HAVE TO BE PUSHED UPWARDS SUCH AS WHEN BEING LOWERED ONTO A RIGID SURFACE (A.G. A BED, THE ARM RESTS OF A CHAIR OR SIDE RAILS OF A TOILET COMMODE CHAIR). THE RATIONALE OFFERED IS THAT THIS SITUATION (THE SPREADER MAY COMPLETELY DETACH FROM THE JIB) DOES NOT POSE A SAFETY HAZARD TO THE PATIENT, AS A THE PATIENT CANNOT BE LIFTED WITH THE HANGER COMPLETELY DETACHED. WE HAVE CONFIRMED REPLACEMENT OF BUSHINGS FOR COMPLAINED MAXI MOVE IN ACCORDANCE TO THIS FSN. FROM ABOVE WE CAN CONCLUDE THAT THIS PROBLEM WAS CAUSED BY USER ERROR SINCE THE CHECKS TO BE PERFORMED BEFORE LIFTING THE PATIENT WERE NOT PERFORMED AND IT IS LIKELY THAT LIFTING ARM CAUGHT SOLID OBJECT WHEN IT WAS BEING LOWERED. INVOLVED DEVICE WAS NOT TO THE SPECIFICATION WHEN THE EVENT OCCURRED, THEREFORE, IT CAN BE STATED THAT THIS PROBLEM WAS CAUSED ALSO BY POOR OR LACK OF MAINTENANCE DUE TO DESCRIBED CONDITION OF COMPLAINED DEVICE. PLEASE NOTE THAT THIS MAXI MOVE LIFT WAS IN USE FOR ABOUT 8 YEARS. HOWEVER, WE CONCLUDE THAT ALTHOUGH THE POOR CONDITION OF DEVICE MIGHT HAVE CONTRIBUTED TO THE SPREADER BAR COMING OFF, THERE IS NO INDICATION THAT THIS IS THE CASE, AND THE MORE LIKELY CAUSE OF THE SPREADER BAR COMING OFF IF NOT PLACING IT ON THE LIFT CORRECTLY AND NOT LOCKING IT IN PLACE CORRECTLY. THE REC'D INFO AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF MAXI MOVE'S WARNINGS AND PREVENTIVE MAINTENANCE WERE FOLLOWED IN ACCORDANCE TO INSTRUCTIONS FOR USE, THERE WOULD NO PATIENT OR CAREGIVER AT RISK.

    Description of Event or Problem · 1

    IMPORTER REPORT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370524 MAXI MOVE FSA ARJO HOSPITAL EQUIPMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1