BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLITES (BOXES OF 10), CLIP

    MDR report key: 5170070 · Received October 23, 2015

    Report

    Report Number
    3007420694-2015-00202
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O. O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING A RESIDENT TRANSFER FROM WHEELCHAIR TO EXAM TABLE THE FLITE (DISPOSABLE SLING) RIPPED AND THE RESIDENT FELL INTO THE WHEELCHAIR. IT CAN BE CONSIDERED THAT THE FLITE RIPPED AT THE START OF THE RESIDENT'S TRANSFER "JUST STARTING TO LIFT, SLING RIPPED, RESIDENT WENT RIGHT BACK DOWN INTO WHEELCHAIR". NO INJURIES WERE SUSTAINED BY THE RESIDENT. THE REVIEW OF REPORTABLE COMPLAINTS WITH FLITES SHOWED THAT THERE ARE NO RELATED EVENTS WHERE THE PERSON FELL DUE TO RIPPED DISPOSABLE (FLITE) SLING. THEREFORE, THE INCIDENT DESCRIBED ABOVE SEEMS TO BE AN ISOLATED EVENT AS OF TODAY. IT CAN BE ESTABLISHED THAT THE LIFT AND THE SLING, WHICH WORK TOGETHER AS A SYSTEM, WERE BEING USED FOR PATIENT CARE WHEN THE EVENT TOOK PLACE, AND AS SUCH IT APPEARS THE SYSTEM PLAYED A ROLE IN THE EVENT OUTCOME. DETAILED INFORMATION REGARDING THE MAXI MOVE LIFT INVOLVED WAS NOT RELEASED. THERE IS NO INDICATIONS THAT PART OF THE LIFT DEVICE FAILED ("NO ISSUES REPORTED BY FACILITY") OR OTHERWISE CONTRIBUTED IN A WAY THAT IS FOUND SIGNIFICANT FOR THIS INVESTIGATION. THEREFORE, THE INVESTIGATION WILL FOCUS ON THE SLING (FLITE) ACCESSORY. AN ON SITE INSPECTION FOUND THE NONWOVEN MATERIAL OF THE FLITE HAVING BEEN RIPPED AT THE SHOULDER PART. BASED ON THIS, THE SYSTEM WAS FOUND TO HAVE MALFUNCTIONED (NOT PERFORMING TO SPECIFICATION) WHEN THE EVENT TOOK PLACE. FOLLOWING THE INFORMATION GATHERED, THE RESIDENT INVOLVED HAS THE WEIGHT EQUAL (B)(6) LBS ((B)(6) KG). WHEN BEARING IN MIND THAT THE SAFE WORKING LOAD OF THIS DISPOSABLE SLING "FLITE" IS (B)(6) KG, THIS CAN BE SEEN AS A CONSIDERABLE SAFETY MARGIN. THIS WAS ALSO CONFIRMED BY OUR TESTS, WHERE SIMULATIONS PERFORMED SHOWED THAT THERE DOES NOT APPEAR TO BE A LIKELINESS OF ANY RIP WHEN THE FLITE IS USED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE FLITE DISPOSABLE SLING CAN TAKE THE FORCES THAT ARE PUT UPON IT DURING THE INTENDED USE. DURING SUCH USE, DAMAGE TO THE MATERIAL IS NOT LIKELY TO OCCUR. THEREFORE, FOR THE FLITE TO HAVE TORN, WE STRONGLY BELIEVE IT TO HAVING BEEN DAMAGED BEFORE TRANSFER OR COULD BE ADDITIONALLY OVERLOADED BECAME CAUGHT IN AN OBSTRUCTION BY BLOCKING IT UNDER SOME OBSTACLE AND LIFTING (A MUCH HIGHER STRAIN). IN ADDITION WE HAVE PREVIOUSLY ALSO SIMULATED USE OF FLITES WHERE THE MATERIAL WAS INTENTIONALLY DAMAGED TO SEE HOW IT WOULD PERFORM DURING NORMAL USE AND ALSO ABUSE. ONLY AFTER SIGNIFICANT ADDITIONAL ABUSE THE FLITE RIPPED FURTHER AT ITS MATERIAL - ACTUALLY IT CAN BE ARGUED THE FAILURES IN THESE SIMULATIONS WERE STILL NOT AS SIGNIFICANT AS THOSE DESCRIBED BY THE CUSTOMER IN THIS EVENT. THIS LEADS US TO BELIEVE THAT THE FLITE IN USE WOULD EITHER HAVE BEEN SEVERELY DAMAGED - WHICH WOULD HAVE MADE THE ISSUE HIGHLY NOTICEABLE - OR THAT THE FLITE WAS NOT USED AS A DISPOSABLE PRODUCT BUT AS A "NORMAL" SLING. THIS THEORY SEEMS TO BE SUPPORTED BY THE FACT THAT THE FLITE WAS FOUND TO BE OF PRODUCTION DATE 2007. A FLITE IS MEANT TO BE USED FOR WEEKS, CERTAINLY NOT 8 YEARS. USING IT THIS LONG OVER ITS LIFETIME WOULD CERTAINLY HAVE PLAYED A BIG FACTOR IN ITS FAILURE AS DESCRIBED. THE DISPOSABLE "FLITE" SLINGS IFU MFA82472M REV 2 SUPPLIED WITH FLITES CONTAINS CRUCIAL INFORMATION: "DURING FLITE UNWRAPPING, AVOID USING SHARP OBJECTS E.G. CUTTING KNIVES. THESE CAN CAUSE PUNCTURES AND CAUSE THE FLITE TO TEAR." "ALWAYS ENSURE THAT THE STRAPS CONNECTING THE SLING TO THE ATTACHMENT CLIPS ARE NOT TWISTED WHEN THE ATTACHMENT CLIPS ARE CONNECTED TO THE SPREADER BAR." "BEFORE EACH USE, CHECK THE FLITE FOR TEARS, RUPTURES, ETC. IF THERE ARE ANY, DO NOT USE THE FLITE BUT DISPOSE OF IT." "ARJO FLITES ARE TO BE USED FOR A LIMITED PERIOD ONLY, AND, BY NATURE OF THEIR DESIGN, MUST BE TREATED AS A DISPOSABLE PRODUCT." THE POSSIBLE SEQUENCES OF EVENT PRESENTED ABOVE SEEMS TO BE THE MOST PROBABLE AND TO BE IN LINE WITH THE EVENT DESCRIPTION. FROM THE INFORMATION AVAILABLE, THE SIMULATIONS PERFORMED AND OUR EVALUATION CONDUCTED WE HAVE COME TO FIND IT MOST LIKELY THAT THE EVENT WAS CAUSED BY USE ERROR : NOT FOLLOWING THE INSTRUCTIONS FOR USE. WE FIND IT LIKELY THAT THE FABRIC RIPPED DUE TO COMBINATION OF BEING DAMAGED BEFORE TRANSFER AND EXCESSIVELY EXCEEDING ITS LIFETIME. PLEASE NOTE THAT THE CUSTOMER WAS VISITED AND INTERVIEWED BY A LOCAL ARJOHUNTLEIGH REPRESENTATIVE BUT COULD NOT PROVIDE ANY TRAINING DATES FOR STAFF. THEREFORE, ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT LIFTING PROCEDURE AND PROPER SLINGS/ FLITES INSPECTION BEFORE USE. THIS IS TO BE COMMUNICATED TO THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE FOLLOWING WAS REPORTED TO ARJOHUNTLEIGH: DURING A PATIENT'S TRANSFER FROM A WHEELCHAIR TO AN EXAM TABLE THE DISPOSABLE SLING RIPPED. IT WAS INDICATED THAT THE ISSUE OCCURRED AT THE BEGINNING OF THE TRANSFER WHILE THE PATIENT WAS LIFTED FROM THE WHEELCHAIR. AS A CONSEQUENCE THE PATIENT "WENT RIGHT BACK DOWN INTO WHEELCHAIR" WITHOUT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700929 FLITES (BOXES OF 10), CLIP FSA FSA ARJOHUNTLEIGH POLSKA SP. Z O. O. MFA1000M-XL 20070703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other