BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINSTREL

    MDR report key: 7788015 · Received August 16, 2018

    Report

    Report Number
    3007420694-2018-00161
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 16, 2018
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MANUFACTURING SITE MEDIBO N.V (UNDER REGISTRATION #3004468271). AS OF 2011, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER SHIPPING PRODUCT TO THE USA AND UNTIL 2014 COMPLAINTS RELATED TO THESE PRODUCTS WERE HANDLED BY ARJOHUNTLEIGH, A BRANCH OF ARJO LIMITED MED AB AND ANY MEDWATCH REPORTS WERE SUBMITTED UNDER REGISTRATION #1000381138. FROM 2014 AND GOING FORWARD COMPLAINTS RELATED TO THESE PRODUCTS ARE TO BE HANDLED BY ARJOHUNTLEIGH AB'S COMPLAINT HANDLING ESTABLISHMENT AND ANY MEDWATCH REPORTS WILL BE SUBMITTED UNDER REGISTRATION #3007420694. ON 19-JUL-1018, ARJO RECEIVED INFORMATION FROM (B)(6) IN ITALY INDICATING THAT DURING USING OF THE ARJO MINSTREL PASSIVE FLOOR LIFT, THE SPREADER BAR (PART ON WHICH THE SLING IS ATTACHED ON) DISCONNECTED FROM THE LIFT. THIS SITUATION TOOK PLACE DURING PATIENT TRANSFER ((B)(6) YEARS OLD FEMALE, WEIGHT: 61.8 KG), ONCE THE RESIDENT WAS ALMOST PLACED IN THE WHEELCHAIR (2 CM ABOVE THE SEAT). NO INJURY OCCURRED. NO MEDICAL INTERVENTION NOR HOSPITALIZATION WAS REQUIRED. BASED ON THE SERIAL NUMBER (B)(6) OF THE INVOLVED DEVICE, IT WAS DETERMINED THAT CLAIMED DEVICE WAS MANUFACTURED IN NOVEMBER 2009 BY THE FORMER MANUFACTURER MEDIBO MEDICAL PRODUCTS LOCATED IN BELGIUM. THE LAST SERVICE WAS CARRIED OUT ON 15-MAY-2018 HOWEVER, THE SPREADER BAR WAS NOT REPLACED IN THE PAST. IT MEANS THAT THE DEFECTIVE SPREADER BAR WAS THE ORIGINALLY FITTED ONE AND IT WAS ABOUT 8.5 YEARS OLD. ANALYSIS OF THE ALL GATHERED INFORMATION REVEALED THAT THE DETACHMENT OF THE SPREADER BAR WAS CAUSED BY THE BREAKAGE OF THE BOLT BETWEEN THE SPREADER BAR AND THE LIFTING ARM (THE LONG-TERM USE COULD CREATE A METAL FATIGUE AND A FORMATION OF MICRO-CRACKS IN THE THREAD) AND BENDING TENSION WHICH CAN OCCUR WHEN USER IS NOT FOLLOWING THE INSTRUCTION FOR USE WARNINGS AND INSTRUCTIONS (E.G. LOAD MASS WAS UNEVENLY PLACED ON SLING; OR LIFT MOVED BY PUSHING/PULLING SUSPENDED PATIENT BODY, SLING OR SPREADER BAR). THE PREVENTIVE MAINTENANCE SCHEDULE SECTION IN OPERATING AND PRODUCT CARE INSTRUCTIONS (MMX15030.EN.M ISSUE 3 DATED ON MAY 2007) INCLUDES INFORMATION REGARDING EVERYDAY INSPECTION: "MAKE SURE ALL EXTERNAL FITTINGS ARE SECURE AND THAT ALL SCREWS AND NUTS ARE TIGHT". ADDITIONALLY, IT IS MENTIONED IN THE OPERATIONAL LIFE SECTION THAT: "THE OPERATIONAL LIFE OF THE MINSTREL IS DEPENDENT ON THE ACTUAL USE CONDITIONS. THEREFORE, BEFORE USE, ALWAYS MAKE SURE THAT THE LIFT IS SAFE TO USE AND HAS NOT BEEN DAMAGED. IF ANY DAMAGE SHOULD BE OBSERVED, DO NOT USE THE MINSTREL". WHEN REVIEWING THE REPORTABLE EVENTS FOR MINSTREL FLOOR LIFT REGISTERED DURING LAST 5 YEARS, WE HAVE FOUND A LIMITED NUMBER OF CASES RELATED TO THE FAILURE OF THE BOLT HOLDING THE SPREADER BAR. THE SPREADER BAR DISCONNECTED FROM THE LIFT DURING THE RESIDENT'S TRANSFER SO THE SYSTEM WAS NOT UP TO THE MANUFACTURER'S SPECIFICATION. THIS COMPLAINT DECIDED TO BE REPORTABLE BASED ON THE POTENTIAL OF SERIOUS INJURY IF THE SPREADER BAR DISCONNECTION WOULD TO RE-OCCURRED DURING TRANSFER WITH A RESIDENT.

    Description of Event or Problem · 0

    ON (B)(6) "1018", ARJO RECEIVED INFORMATION FROM (B)(6) INDICATING THAT DURING USING OF THE ARJO MINSTREL PASSIVE FLOOR LIFT, THE SPREADER BAR (PART ON WHICH THE SLING IS ATTACHED ON) DISCONNECTED FROM THE LIFT. THIS SITUATION TOOK PLACE DURING PATIENT TRANSFER ((B)(6) FEMALE, (B)(6)), ONCE THE RESIDENT WAS ALMOST PLACED IN THE WHEELCHAIR (2 CM ABOVE THE SEAT). NO INJURY OCCURRED. NO MEDICAL INTERVENTION NOR HOSPITALIZATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632814 MINSTREL LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO MEDICAL PRODUCTS NV HMA0011

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other