BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI MOVE

    MDR report key: 8653596 · Received May 30, 2019

    Report

    Report Number
    9681684-2019-00052
    Event Type
    Death
    Date Received
    May 30, 2019
    Date of Event
    May 3, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012068 BY THE ARJOHUNTLEIGH MAGOG INC. (REGISTRATION #9681684) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652).ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. ON (B)(6) 2019 ARJO HAS BECOME AWARE OF THE EVENT INVOLVING MAXI MOVE PASSIVE FLOOR LIFT AND A SLING (NO-ARJO PRODUCT), WHICH OCCURRED IN (B)(6) CARE HOME LOCATED IN (B)(6). IT WAS REPORTED THAT ADVERSE EVENT OCCURRED DURING RESIDENT TRANSFER. THE CUSTOMER PROVIDED INFORMATION THAT RESIDENT FELL OUT FROM THE SLING ON MAXI MOVE DEVICE. AS A CONSEQUENCE OF THE EVENT THE RESIDENT SUSTAINED FRACTURE OF FIBULA AND TIBIA AND BLEED TO THE BRAIN. ARJO REPRESENTATIVE CONDUCTED THE DEVICE EVALUATION AT THE CUSTOMER FACILITY. THE FUNCTIONAL AND VISUAL INSPECTION SHOWED THAT THE DEVICE WAS IN GENERAL GOOD CONDITION, NO MALFUNCTION WAS DETECTED. THE DEVICE WAS WORKING ACCORDING TO THE MANUFACTURER'S SPECIFICATION. IT WAS CONFIRMED THAT DURING THE EVENT CUSTOMER USED THE NON-ARJO CLIP SLING. DURING THE VISIT ARJO SERVICE TECHNICIAN WAS UNABLE TO GATHERED ANY ADDITIONAL INFORMATION. THE MAXI MOVE INSTRUCTION FOR USE (001.25060 REV.10) CONTAINS THE FOLLOWING INFORMATION: " MAXI MOVE MUST ALWAYS BE HANDLED BY A TRAINED CAREGIVER AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THIS MANUAL.: "MAXI MOVE IS INTENDED TO BE USED WITH ARJOHUNTEIGH SLINGS. ONLY USE SLINGS AND STRETCHERS SUPPLIED BY ARJOHUNTLEIGH THAT ARE DESIGNED TO BE USED WITH YOUR MAXI MOVE". PATIENT OR USER IS NOT IN ANY IMMEDIATE DANGER AND IS NOT EXPOSED TO A RISK TO HEALTH, AS LONG AS THE DEVICE IS USED ACCORDING TO LABELING AND IN PARTICULAR, THE PROPER ARJO SLING IS USED AND IS CORRECTLY ATTACHED TO THE DEVICE. DESPITE OUR BEST EFFORT, THE CUSTOMER DID NOT REVEAL ANY ADDITIONAL INFORMATION REGARDING THE EVENT CIRCUMSTANCES. WHEN REVIEWING SIMILAR REPORTABLE EVENTS SINCE LAST 5 YEARS, WE HAVE FOUND 2 COMPLAINTS WHERE UNAUTHORIZED ACCESSORY (NO ARJO SLING) AS USED WITH MAXI MOVE DEVICES. SUM UP, WHILE THE EVENT OCCURRED THE ARJO DEVICE WAS BEING USED FOR THE PATIENT'S HANDLING. NO TECHNICAL MALFUNCTION OF THE DEVICE WAS DETECTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO ADVERSE EVENT AND FROM THAT PERSPECTIVE, THE FLOOR LIFT DEVICE WAS UP TO ITS TECHNICAL SPECIFICATION AT THE TIME OF THE EVENT. THE SLING USED BY THE FACILITY WAS A NON-ARJO PRODUCT. WE REPORT THIS EVENT TO THE COMPETENT AUTHORITY BASED ON THE REPORTED INJURIES SUSTAINED BY THE RESIDENT AFTER THE EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2019 ARJO HAS BECOME AWARE OF THE EVENT INVOLVING MAXI MOVE PASSIVE FLOOR LIFT AND A SLING (NO-ARJO PRODUCT), WHICH OCCURRED IN (B)(6) CARE HOME LOCATED IN (B)(6). IT WAS REPORTED THAT ADVERSE EVENT OCCURRED DURING RESIDENT TRANSFER. THE CUSTOMER PROVIDED INFORMATION THAT RESIDENT FELL OUT FROM THE SLING ON MAXI MOVE DEVICE. AS A CONSEQUENCE OF THE EVENT THE RESIDENT SUSTAINED FRACTURE OF FIBULA AND TIBIA AND BLEED TO THE BRAIN.

    Description of Event or Problem · 0

    ON (B)(6) 2019 ARJO WAS INFORMED THAT THE PATIENT HAS PASSED AWAY. NO OTHER INFORMATION WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446345 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. KMCSXN-D

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| R