BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLINGS, CLIP

    MDR report key: 6367575 · Received March 1, 2017

    Report

    Report Number
    3007420694-2017-00046
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Report Date
    June 12, 2017
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSIONS OF THE MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION HAS BEEN AMENDED IN FOLLOWING SECTIONS: B5, H6. THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS INITIALLY ALLEGED THAT DURING THE TRANSFER OF RESIDENT, ONE OF SLING CLIP BROKE. HOWEVER, IN THE COURSE OF INVESTIGATION AND ALONG WITH NEW INFORMATION RECEIVED, IT WAS ESTABLISHED THAT BUCKLE OF ACTIVE SLING WAS FOUND DAMAGED. THE FAULT WAS DISCOVERED BY FACILITY BEFORE USE. IT WAS REPORTED THAT FAULTY SLING WAS FOUND BY LAUNDRY. AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. WHEN REVIEWING REPORTABLE EVENTS, WE HAVE NOT FOUND A REPORTABLE COMPLAINTS WITH SIMILAR FAULT DESCRIPTION. IT HAS BEEN ESTABLISHED THAT ACTIVE SLING DEDICATED FOR SARA 3000 LIFT WAS NOT BEING USED FOR PATIENT HANDLING AT THE TIME OF THE EVENT. THE SLING WAS FOUND TO HAVE NOT BEEN TO SPECIFICATION - THE MALE BUCKLE WAS FOUND BROKEN. THE ARJOHUNTLEIGH ACTIVE SLINGS ARE THE PRODUCTS INTENDED FOR ASSISTED TRANSFER AND REHABILITATION OF RESIDENTS WITH LIMITED ABILITY TO MOVE. BUCKLE IN ACTIVE SLINGS IS A FASTENING FOR TWO LOOSE ENDS THAT IS ATTACHED TO ONE AND HOLDS THE OTHER BY A CATCH. THERE ARE TWO KINDS OF THE BUCKLES: MALE AND FEMALE. THE MALE BUCKLE HAS PRONGS, WHICH DURING MOUNTING CONNECTS WITH THE FEMALE BUCKLE BY POSITIVE CONNECTION.THE BUCKLE IS USED TO SECURELY FASTEN THE SUPPORT STRAP. THE SLING SUPPORT STRAP RETAINS THE SLING IN THE CORRECT POSITION AROUND THE RESIDENT. NOTE THAT THE CHEST SUPPORT STRAP DOES NOT HAVE A WEIGHT BEARING FUNCTION, BUT IS RATHER PUT IN PLACE TO KEEP THE SLING IN THE CORRECT POSITION AROUND THE RESIDENT. SLINGS ARE CONSUMABLE ITEMS, WHEN USED AND CARED FOR WITHIN THE INTENDED USE OF BOTH THE LIFT AND SLING, THEY CAN BE USED CONSISTENTLY FOR A LONG PERIOD OF TIME, WITHOUT PROBLEM. HOWEVER DUE TO ITS CONSUMABLE NATURE, THE SLING IS TO BE DISCARDED WHEN SLING FAILURES OCCURS AND IT WAS DONE IN THIS CASE. ACCORDING TO THE SLING INSTRUCTION FOR USE (IFU), THE EXPECTED LIFETIME (...) IS DEPENDENT ON THE ACTUAL USE CONDITIONS. THEREFORE, BEFORE USE, ALWAYS MAKE SURE THAT THE SLING DOES NOT SHOW ANY SIGNS OF FRAYING, TEARING OR OTHER DAMAGE (FOR EXAMPLE CLIPS OR BUCKLES). THE SLINGS MUST BE MAINTAINED IN ACCORDANCE WITH PUBLISHED IN IFU. THE RECOMMENDED PERIOD OF USE IS 2 YEARS. IN THIS PARTICULAR CASE, THE SERIAL NUMBER WAS NOT PROVIDED THEREFORE WE CANNOT ESTABLISH MANUFACTURING DATE OF SLING. ADDITIONALLY, FOLLOWING PRODUCT KNOWLEDGE AND PREVIOUS SIMULATIONS, IT APPEARS A FAILURE IS NOT LIKELY TO COME FROM ON LABEL USE. THE ACTIVE SLINGS SHALL ONLY BE USED BY APPROPRIATELY TRAINED CAREGIVERS WITH ADEQUATE KNOWLEDGE OF THE CARE ENVIRONMENT, ITS COMMON PRACTICES AND PROCEDURE AND IN ACCORDANCE WITH THE IFU. ANYONE USING THE EQUIPMENT MUST ALSO HAVE READ AND UNDERSTOOD THE INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU) PROVIDED FOR EACH DEVICE BY MANUFACTURER. FOLLOWING PRODUCT KNOWLEDGE AND PREVIOUS SIMULATIONS, ALL SITUATIONS, WHICH ARE CLEARLY RELATED WITH A DAMAGE OF BUCKLE CAUSED BY EXCESSIVE FORCE (USAGE OF EXTERNAL TOOLS/ SHARP OBJECTS; THE BUCKLE HAS BEEN STEPPED; THE LIFT PASS ON THE BUCKLE SLING; USER LOST THE BUCKLE; THE SLING FACED AN OBSTACLE; ETC.) ARE CONSIDERED TO BE USER ERRORS. IT SHOULD BE POINTED OUT THAT DAMAGED BUCKLE WAS FOUND BY LAUNDRY. PLEASE NOTE THAT SLING LABELLING INDICATES NOT TO USE A DRYING PRESS. THEREFORE, POSSIBLY THE WASHING INSTRUCTIONS WERE NOT FOLLOWED. AFTER THIS REVIEW, WE CAN STATE THE COMPLAINT OUTCOME OF A DAMAGED BUCKLE OF SLING, IS NOT LIKELY TO HAPPEN WHEN FOLLOWING THE DEVICE LABELLING OR THE IFU. ALTHOUGH NO SERIOUS INJURY TOOK PLACE, WE HAVE REPORTED THIS EVENT TO COMPETENT AUTHORITIES IN ABUNDANCE OF CAUTION, DUE TO INITIAL ALLEGATION THAT PASSIVE SLING CLIP BREAKAGE WAS NOTICED DURING TRANSFER OF THE RESIDENT. HOWEVER, IN THE COURSE OF INVESTIGATION AND ALONG WITH NEW INFORMATION RECEIVED THAT BUCKLE OF ACTIVE SLING WAS FOUND DAMAGED BEFORE USE OF SLING, ARJOHUNTLEIGH NO LONGER FIND THIS EVENT TO COMPROMISE PATIENT'S OR USERS SAFETY.

    Description of Event or Problem · 0

    ON 06TH FEBRUARY 2017 ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING THE TRANSFER OF RESIDENT WITH SLING, ONE OF SLING CLIP CRACKED. RESIDENT FELL AS CONSEQUENCES AND SUSTAINED A BRUISE AT HEAD.

    Description of Event or Problem · 0

    ON (B)(6) 2017 ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING THE TRANSFER OF RESIDENT WITH SLING, ONE OF SLING CLIP CRACKED. RESIDENT FELL AS CONSEQUENCES AND SUSTAINED A BRUISE AT HEAD. HOWEVER, IN COURSE OF THE INVESTIGATION AND BASED ON THE PROVIDED DATA IT WAS CONFIRMED THAT BUCKLE OF ACTIVE SLING DEDICATED FOR SARA 3000 WAS FOUND BROKEN. ON (B)(6) 2017 IT WAS CONFIRMED THAT MALE BUCKLE OF TSS.501 SLING WAS FOUND BROKEN BY LAUNDRY IN CUSTOMER FACILITY. NO PATIENT INVOLVEMENT WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152376 SLINGS, CLIP NON-AC-POWERED PATIENT LIFT FSA ARJOHUNTLEIGH POLSKA SP. Z O.O. TSS.501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other