BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINSTREL

    MDR report key: 6025367 · Received October 13, 2016

    Report

    Report Number
    3007420694-2016-00212
    Event Type
    Injury
    Date Received
    October 13, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    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). AN INVESTIGATION WAS PERFORMED ON THIS COMPLAINT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR ALL DEVICES IN THE MARKET AND OVER A PERIOD OF FIVE YEARS, WE HAVE FOUND A NUMBER OF CASES THAT MAY RELATE TO THE ISSUE INVESTIGATED HERE. WE HAVE BEEN ABLE TO ESTABLISH THAT COMPARED TO THE AMOUNT OF SOLD DEVICES AND IN COMPARISON TO THEIR DAILY USE THE OCCURRENCE RATE OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE IS LOW. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. FROM SERVICE HISTORY IT TURNS OUT THAT LIFT MINSTREL DEVICE WITH SERIAL NUMBER (B)(6) WAS UPGRADED PER FIELD ACTION Z-0970-04 BY ARJOHUNTLEIGH IN MAY 2004. UNFORTUNATELY AND DESPITE OUR BEST EFFORTS FURTHER INFORMATION CONCERNING THE DEVICE HISTORY HAS NOT BEEN MADE AVAILABLE - THE DEVICE WAS NOT UNDER ARJOHUNTLEIGH SERVICE. THE SERVICE AND TECHNICAL SUPPORT IS ESSENTIAL TO PROVIDE THE OPTIMAL PROTECTION AND PERFORMANCE OF THE FLOOR LIFT. THE EXPECTED OPERATIONAL LIFE TIME OF MINSTEL PASSIVE HOIST IS TEN (10) YEARS. THE DEVICE HAS REACHED ITS INTENDED AND LABELLED LIFETIME OF TEN YEARS IN 2011. THIS MEANS THAT THE DEVICE HAS BEEN IN USE FOR ABOVE FIFTEEN (15) YEARS. THERE APPEAR TO HAVE BEEN NO COMPLAINTS SINCE THE DEVICE WAS DELIVERED TO THE CUSTOMER, UP UNTIL THE EVENT TOOK PLACE. BASED ON COLLECTED INFORMATION, FINDINGS MADE DURING THE INSPECTION OF THE INVOLVED CEILING DEVICE CONDUCTED BY A QUALITY ENGINEER AT THE CUSTOMER SITE, AS WELL AS AN ATTEMPT TO RECREATE THE EVENT, WE (ARJOHUNTLEIGH) HAVE BEEN ABLE TO ESTABLISH THAT THE MOST PROBABLE ROOT CAUSE OF FAULT OF THIS MINSTREL WAS USE ERROR AS THE SERVICE INSTRUCTION FOR THIS DEVICE HAD NOT BEEN FOLLOWED. ADDITIONALLY THE AGE OF THE INVOLVED DEVICE INDICATES THAT ITS OPERATIONAL LIFETIME WAS ALREADY EXCEEDED. IT SHOULD BE ALSO EMPHASIZED THAT AS WITH ALL OF OUR DEVICES AND THEIR COMPONENTS, CARE MUST BE PRACTICED SO AS TO PRESERVE THE QUALITY AND LIFE OF THE DEVICE AND ITS COMPONENTS. IN ACCORDANCE TO INSTRUCTION FOR USE, THAT IS ATTACHED WITH EACH MINSTREL DEVICE BEFORE EVERY USE THE INSPECTION OF THE SPREADER BAR FOR A DAMAGES OR CRACKS SHOULD BE CONDUCTED BY THE USER. INSPECTION OF THE DEVICE CONDUCTED BY THE ARJOHUNTLEIGH REPRESENTATIVES FOUND OUT MULTIPLE SIGNS OF THE RUST ON THE METAL COMPONENTS. THE DEVICE WAS FOUND IN WEAK CONDITION AND WAS NOT IN FUNCTIONING ORDER. THE BOLT AND THE NUT THAT HOLD THE HANGER BAR ON THE LIFTING ARM WERE BROKEN OFF. IT HAS BEEN CONFIRMED BY THE ARJOHUNTLEIGH FIELD SERVICE REPRESENTATIVE THAT NO ARJOHUNTLEIGH SERVICE OR PREVENTATIVE MAINTENANCE HAS BEEN PERFORMED ON THIS EQUIPMENT IN THE LAST 12 YEARS. THIS IN COMBINATION WITH THE CUSTOMER NOT BEING ABLE TO SHOW EVIDENCE OF ANY OTHER MAINTENANCE ACTIVITIES, DESPITE BEING ASKED, IT APPEARS THE SERVICE HAS NOT BEEN PERFORMED BY AN ARJOHUNTLEIGH-TRAINED SERVICE TECHNICIAN. THEREFORE AT MINIMUM IT CAN BE STATED THAT THE LOCKING DEVICES WERE NOT CHECKED FOR THEIR WORKING CONDITION. FOR AN ARJOHUNTLEIGH TRAINED -AND ARGUABLY EVEN FOR AN UNTRAINED- SERVICE TECHNICIAN THIS APPEARS TO BE AN OBVIOUS FAILURE OF CORRECT MAINTENANCE OCCURRED. IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. THERE WAS SPREADER BAR DEFICIENCY FOUND AND FROM THAT PERSPECTIVE THE SYSTEM WAS NOT UP TO SPECIFICATION AT THE TIME OF THE INCIDENT. WE ARE GOING TO MONITOR THE SIMILAR NATURE OF COMPLAINT AND IF THESE WOULD ARISE, INITIATE THE APPROPRIATE ACTIONS.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH RECEIVED CUSTOMER COMPLAINT WHERE IT WAS REPORTED THAT DURING THE TRANSFER FROM THE BED, THE HANGER BAR CAME OFF THE LIFT ARM AND THE RESIDENT FELL AT THE EDGE OF THE BED. AS A RESULT, THE RESIDENT RECEIVED A SKIN TEAR ON THE ELBOW, HAD BRUISED HEAD AND LIP. TWO STAPLES ON THE ELBOW WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676303 MINSTREL NON-AC-POWERED PATIENT LIFT FSA MEDIBO MEDICAL PRODUCTS NV

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization