BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI MOVE

    MDR report key: 3022536 · Received March 21, 2013

    Report

    Report Number
    9611530-2013-00026
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Removal / Correction Number
    Z-2470-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MANUFACTURER (B)(4) ON BEHALF OF THE IMPORTER (B)(4). SINCE THERE WAS NO CLEAR DETAILS REPORTED ON THE FAILURE MODE INVOLVED IN THE EVENT, AND SINCE NO MALFUNCTION COULD BE FOUND DURING THE SUBSEQUENT ON-SITE VISIT, NO TREND REVIEW COULD BE PERFORMED. CONCERNING THE DEVICE, THERE WAS NO MANUFACTURING ANOMALIES WHEN CONSULTING THE DHR. THE DEVICE WAS SUBJECT TO A FIELD ACTION (FDA REFERENCE NUMBER Z-2470-2008), RELATED TO UNINTENDED DISLOCATION OF THE HANGER ON MAXI MOVES EQUIPPED WITH THE LOCK AND LOAD SYSTEM. THE EXECUTION OF THE FIELD ACTION WAS CONFIRMED. THERE WAS NO RECORDED SERVICE HISTORY PROVIDED, THE PREVENTIVE MAINTENANCE BEING PERFORMED BY THE FACILITY. AN ONSITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH REPRESENTATIVE AFTER THE INCIDENTS. HE COULD NOTICE THAT THE LIFT WAS IN GOOD CONDITION, WITH TYPICAL SCRATCHES ON THE LEGS AND CHASSIS. THE TOP AND BOTTOM JIB COVERS WERE BROKEN AND HELD TOGETHER WITH TAPE. THE LIFT WAS WORKING TO MANUFACTURING SPECIFICATIONS ESPECIALLY CONCERNING THE HANGER BAR ATTACHMENT; IT COULD NOT BE REMOVED SIMPLY BY LIFTING UPWARD. THE EVENT COULD NOT BE RE-CREATED AND NO ONE COULD EXPLAIN THE GAP BETWEEN THE INITIAL DECLARATION OF EVENT AND THE SEQUENCE OF EVENTS DESCRIBED AT SITE VISIT WHICH POTENTIALLY LEAD TO THE ALLEGED RISKY SITUATION. SINCE NO MALFUNCTION COULD BE CONFIRMED WITH THE DEVICE, NO PRODUCT RETURN WAS DEEMED NECESSARY. BASED ON THE LACK OF DETAILS REGARDING THE EVENT ITSELF, THERE IS NO STARTING POINT TO PERFORM A ROOT CAUSE ANALYSIS. THERE ARE A WIDE VARIETY OF KNOWN AND POSSIBLY UNKNOWN FAILURE MODES WHICH COULD CAUSE A HANGER BAR TO END UP ON THE PT. HOWEVER, THE DEVICE CONDITION WAS EVALUATED AFTER THE EVENT DURING THE ON-SITE VISIT DOES NOT ALLOW IDENTIFYING ANY FAILURE MODE. THEREFORE, THE ROOT CAUSE IS UNDETERMINED. THE INFORMATION WILL BE UPDATED IF FURTHER DETAILS ARE AVAILABLE. IT HAS BEEN SUGGESTED THE FACILITY TO PROVIDE DETAILS REGARDING THE SEQUENCE OF EVENT, SO THAT A THOROUGH INVESTIGATION PROCESS CAN BE PERFORMED. FOR THE CURRENT EVENT, THE INFORMATION ABOUT HOW THE HANGER BAR ENDED UP ON THE PT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    CAREGIVERS HAVE BEEN WEIGHED PT WITH THE FLOOR LIFT. THE PT WAS LAYING IN HIS BED ON TOP OF THE SLING. CAREGIVER MOVED THE LIFT TO POSITION THE HANGER BAR OVER THE PT TO HOOK THE SLING CLIPS WHEN THE HANGER BAR DROPPED ON TOP OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117653 MAXI MOVE MANUFACTURED FLOOR PASSIVE LIFT FSA ARJO HOSPITAL EQUIPMENT AB KMBB4OLU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1