BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER 600

    MDR report key: 6173137 · Received December 14, 2016

    Report

    Report Number
    9681684-2016-00063
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    October 13, 2016
    Report Date
    February 11, 2017
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILLED BY THE MANUFACTURER ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684). ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT WHERE IT WAS INDICATED THAT DURING THE RESIDENT'S TRANSFER BY THE HOYER LIFT, THE RESIDENT SLID OUT OF THE SLING. AN INVESTIGATION WAS CARRIED OUT REGARDING THIS INCIDENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND A NUMBER OF CASES WITH SIMILAR GENERAL FAULT DESCRIPTION (SLIP OUT OF SLING). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE IS CURRENTLY CONSIDERED TO BE LOW AND STABLE. THE HOYER LIFT WAS INSPECTED. NO MALFUNCTIONS REGARDING LIFT WERE INDICATED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT WAS REPORTED THAT NONE OF SLING HAD LABELS ("MOSTLY OLD AND TIRED"). EVEN ALTHOUGH WE DO NOT BELIEVE SUCH WEAR IS CONTRIBUTING FACTOR, THIS IS AN INDICATION THAT THE SLING SHOULD HAVE BEEN WITHDRAWN FROM USE AND REPLACED, WHAT CONSTITUTES THAT THE IFU WAS NOT FOLLOWED. THE SLING AND THE LIFT WERE BEING USED FOR PATIENT HANDLING BUT IT APPEARS IT CONTRIBUTED TO THE EVENT POSSIBLY DUE TO A USE ERROR. A DRILL DOWN ANALYSIS WAS CONDUCTED INTO THIS EVENT. BASED ON OUR PRODUCT KNOWLEDGE AND MANY SIMULATIONS PERFORMED FOR MANY SLINGS TYPES THERE ARE FEW ELEMENTS WHICH COULD CONTRIBUTE TO A PERSON SLIDING OUT FROM THE SLING: - INADEQUATE SLING SIZE USED FOR TRANSFER. - IF THE SLING IS AT LEAST 2 SIZES TOO BIG A GAP BETWEEN THE LEG STRAPS IS BIGGER THAN IT SHOULD BE AND IT APPEARS LIKELY THAT A PERSON IN A SLING COULD SLIDE OUT AS THE GAP WOULD BE BIG ENOUGH. - NOT APPROPRIATE SLING MODEL USED FOR TRANSFER THE SLING MODEL WAS NOT PROVIDED. HOWEVER, THERE IS NO INDICATION THAT THE SLING WAS NOT APPROPRIATE FOR THE PATIENT'S TRANSFER DURING EVENT IN QUESTION. - SLING NOT CORRECTLY ATTACHED/APPLIED TO THE LIFT BASED ON MANY SIMULATIONS PERFORMED REGARDING MANY TYPES OF SLINGS WE CAN DETERMINE THAT LACK OF SLING ATTACHMENT COULD LEAD TO A PERSON SLIPPING AND FALLING. - WRONG POSITION OF THE PATIENT IN THE SLING (E.G.: SLING USED UPSIDE DOWN, WRONG POSITION OF THE RESIDENT/PATIENT ARMS). HOWEVER, DUE TO VERY LIMITED INFORMATION RECEIVED THE NONE OF THE ABOVE SCENARIOS CAN BE RULED OUT. FOLLOWING INFORMATION DOCUMENTED IN THE COMPLAINT FILE, WHEN CAREGIVERS "WERE MOVING THE LIFT, THE LEG OF THE LIFT HIT THE LEG OF THE BED", WHICH ALSO INDICATES THAT THE IFU WAS NOT FOLLOWED. THE HOYER LIFT (HPL 600) INSTRUCTION FOR USE WARNS: "ALWAYS PLACE THE SLING AROUND THE USER ACCORDING TO THE SLING USER INSTRUCTIONS." "ALWAYS BE PREPARED BEFORE ATTEMPTING TO TRANSFER A PERSON" "DO NOT ATTEMPT TO MANEUVER THE LIFT BY PUSHING ON THE MAST, MOTOR SAFT, BOOM OR USER. ALWAYS MANEUVER THE LIFT WITH THE HANDLE PROVIDED". FROM THIS EVALUATION, IT WOULD APPEAR MOST LIKELY THAT THE EVENT WAS CAUSED BY THE USER NOT FOLLOWING RECOMMENDATIONS GIVEN IN THE IFU, DUE TO LACK OF AWARENESS OF THE ITS CONTENTS. WE FIND THIS CAUSE TO BE RELATED TO LACK OR INSUFFICIENT TRAINING. ARJOHUNTLEIGH SUGGESTS TO REMIND THE STAFF INVOLVED OF THE DEVICE LABELLING, WITH SPECIAL ATTENTION TO CORRECT APPLICATION AND CHECKING OF THE SLING BEFORE TRANSFER. THEREFORE, RE TRAINING FOR THE STAFF INVOLVED WILL BE SUGGESTED. THIS IS TO BE COMMUNICATED TO THE CUSTOMER. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 16 NOVEMBER 2016 ARJOHUNTLEIGH HAS RECEIVED FDA REPORT (3009402404 2016 00043) FROM (B)(4), THE US IMPORTER OF THE DEVICE. AS PER THE MDR PROVIDED, IT WAS REPORTED BY (B)(4) TO ARJOHUNTLEIGH (B)(4) THAT: "IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER 2 AIS WERE TRANSFERRING PATIENT FROM RECLINER TO BED. WHEN THEY WERE MOVING THE LIFT, THE LIFT WAS ALL THE WAY UP IN THE AIR AND THE LEG OF THE LIFT HIT THE LEG OF THE BED. THE PATIENT SLID OUT OF THE SLING AND SHE WAS LOWERED TO THE GROUND. HER FOOT HIT THE FOOT BOARD OF HER BED, THUS CAUSING THE FRACTURE. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND WAS DIAGNOSED WITH A CLOSED FRACTURE TO THE LEFT ANKLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824161 HOYER 600 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. HPL600WBSC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization