BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI MOVE

    MDR report key: 4143517 · Received September 3, 2014

    Report

    Report Number
    9611530-2014-00067
    Event Type
    Injury
    Date Received
    September 3, 2014
    Manufacturer
    ARJO MED AB LTD
    Product Code
    FSA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS PRODUCT TIS NO LONGER MANUFACTURED AND PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE ARJO MED. AB LTD (UNDER REGISTRATION #9617021). AS OF (B)(4) 2010, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MANUFACTURER. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJO HOSPITAL EQUIPMENT AB AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #9611530. IT WAS INITIALLY REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING THE PT'S TRANSFER FROM THE WHEELCHAIR TO THE BED USING THE MAXI MOVE PASSIVE LIFT DEVICE, ONE OF THE SLING CLIP DETACHED FROM THE SPREADER BAR DUE TO INCORRECT SLING INSTALLATION OF THE SLING PROVIDED BY THE CAREGIVER. IN CONSEQUENCE THE PT FELL DOWN AND RECEIVED HEAD TRAUMA BUT NO BLEEDING OR FRACTURE OCCURRED. FORM THE INFORMATION RECEIVED IT WAS INDICATED THAT THE PT'S INJURY WAS NOT SERIOUS AND THAT THE PT WAS HOSPITALIZED ONLY DUE TO OLD AGE AND JUST FOR PREVENTIVE ACTION, WITHOUT ANY TREATMENT OR CONSEQUENCES. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTION (CLIP DETACHMENT). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE RELATIVELY LOW AND STABLE. IT HAS BEEN ESTABLISHED THAT THE LIFT DEVICE (MAXI MOVE) AND THE CLIP SLING SYSTEM WAS BEING USED FOR PT HANDLING AT THE TIME OF THE EVENT. THE LIFT AND THE SLING WERE FOUND TO HAVE BEEN TO SPECIFICATION FROM A FUNCTIONAL PERSPECTIVE WHEN THE EVENT TOOK PLACE. THE LIFT AND THE SLING DEVICE WERE INSPECTED AND NO MALFUNCTION WERE INDICATED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A SLING CLIP, ONCE CORRECTLY ATTACHED AND MONITORED TO STAY IN PLACE AS THE WEIGHT OF THE PERSON IN THE SLING IS GRADUALLY TAKEN UP, AS INDICATED TO BE REQUIRED IN THE LABELLING, IS LOCKED IN POSITION WITH THE WEIGHT OF THE PT. IT IS NOT LIKELY TO COME OFF DURING ON-LABEL USE. BASED ON PRODUCT KNOWLEDGE AND PREVIOUSLY MADE SIMULATIONS THIS THEN LEAVES OPEN A POSSIBLE SEQUENCE OF EVENT: FROM THE INFORMATION RECEIVED IT APPEARS MORE LIKELY THAT THE SLING WAS APPLIED TO THE PERSON ON THE WHEELCHAIR (VERTICAL POSITION) WITH THE CLIPS ATTACHED TO THE HANGER BAG. AS IT WAS INDICATED ONE OF THE CLIP OF THE SLING DETACHED FORM THE SPREADER BAR DUE TO INCORRECT INSTALLATION OF THE SLING PROVIDED BY THE CAREGIVER. IT APPEARS MORE LIKELY THAT THE CLIP WAS NOT IN PLACE AT THE START OF THE LIFTING PROCEDURE AND COULD WIGGLE OFF WHEN THE CLIP AND STRAP WERE NOT UNDER TENSION YET. IF THE LABELLING IS FOLLOWED THERE CAN BE NO ISSUE. HOWEVER, IT IS POSSIBLE FOR THE CAREGIVERS TO NOT HAVE FOLLOWED THE LABELLING AND NOT CHECKED THE CLIPS ARE CORRECTLY ATTACHED AND REMAIN IN TENSION AS THE WEIGHT OF THE RESIDENT IS GRADUALLY TAKEN UP. THE USER IS OBLIGED TO MONITOR THE CLIPS BECOMING UNDER TENSION WHEN THE WEIGHT OF THE PT IS GRADUALLY BEING LOADED ON. WE COME TO THE CONCLUSION THAT THERE WAS A USE ERROR THAT CAUSED THE EVENT. THE INSTRUCTIONS FOR USE THAT INDICATE: TO MAKE SURE ALL CLIPS ARE IN PLACE AND REMAIN IN PLACE AND THE CLIP STRAPS COME UNDER TENSION AS THE WEIGHT OF THE PERSON IN THE SLING IS GRADUALLY TAKEN UP. TRAINING DATE FOR THE INVOLVED STAFF WAS RECEIVED BUT TURNED OUT TO BE INSUFFICIENT TO ENSURE TOP-OF-MIND AWARENESS AND ATTENTION. IN THE LABELLING THERE IS A PARTICULAR ATTENTION TO AVOID THESE ISSUES, AND TO HIGHLIGHT THE RESPONSIBILITY OF THE DEVICE OWNER TO MAKE SURE THAT THE DEVICE USERS ARE TRAINED AND KNOWLEDGEABLE OF THE CONTENTS OF THE LABELLING. WHEN THE IFU WOULD HAVE BEEN FOLLOWED, THE EVENT WOULD HAVE BEEN AVOIDED. FROM THIS EVALUATION IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING THE IFU, DUE TO LACK OF AWARENESS OF THE IFU CONTENTS. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Description of Event or Problem · 1

    REF IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535916 MAXI MOVE FSA ARJO MED AB LTD

    Patients

    Seq Age Sex Outcome Treatment
    1