BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 440

    MDR report key: 8472740 · Received April 2, 2019

    Report

    Report Number
    9681684-2019-00029
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 4, 2019
    Report Date
    May 24, 2019
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 CONCLUSIONS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON 2019-MAR-04 ARJO WAS INFORMED ABOUT INCIDENT RELATED TO ARJO MAXI SKY 440 PORTABLE CEILING LIFT. IT WAS REPORTED THAT DURING TRANSFER FROM BED TO CHAIR, WHEN THE RESIDENT WAS BEING LIFTED UP FOR A FEW CENTIMETERS, THE PORTABLE CEILING LIFT DETACHED FROM THE CARABINER AND FELL TOGETHER WITH THE RESIDENT TO THE BED. FORTUNATELY, NO INJURY WAS SUSTAINED. STATISTICAL ANALYSIS OF THE SIMILAR REPORTABLE EVENTS REGISTERED DURING LAST YEARS SHOWN NO SIGNIFICANT TREND OF THE COMPLAINTS WITH SIMILAR FAULT DESCRIPTION - PORTABLE CEILING LIFTS DETACHMENT DUE TO FAILURE IN ATTACHMENT OF THE CARABINER. THE DEVICE HAS BEEN IDENTIFIED AS MAXI SKY 440 CEILING LIFT WITH MODEL NUMBER LE00000-EUUK AND SERIAL NUMBER 300098957. IT WAS MANUFACTURED ON 2015-SEP-29 IN ARJOHUNTLEIGH MAGOG (CANADA). THE LIFTING SYSTEM CONSISTS OF THE CEILING INSTALLATION WITH TRACK TROLLEY, WHICH IS CONNECTED WITH THE LIFTING UNIT STRAP VIA CARABINER. MAXI SKY 440 IS A PORTABLE DEVICE, WHICH MEANS THAT THE LIFTING UNIT CAN BE EASILY DISCONNECTED FROM ONE INSTALLATION AND CONNECTED TO ANOTHER ONE. THE REACHER ACCESSORY IS USED FOR FACILITATING THIS OPERATION. IN THE INVESTIGATED CASE, THE LIFTING UNIT HAS DISCONNECTED FROM THE CEILING INSTALLATION IN PLACE WHERE THE STRAP IS ATTACHED TO CARABINER. ARJO REPRESENTATIVE, WHO EXAMINED THE DEVICE AFTER EVENT, DID NOT FIND ANY MALFUNCTION OF THE CEILING LIFT, REACHER OR CARABINER. FOLLOWING THE FACILITY STAFF EXPLANATION OF THE REASON OF THE REPORTED DETACHMENT, IT SEEMS MOST PROBABLE THAT THE CARABINER WAS NOT ATTACHED CORRECTLY. FROM OUR PRODUCT KNOWLEDGE, REVIEW OF PREVIOUS COMPLAINTS AND ALSO SIMULATION PERFORMED, IT HAS BEEN CONCLUDED THAT A DETACHMENT OF THE CEILING LIFT STRAP IS HIGHLY UNLIKELY IF THE STRAP INSIDE THE CARABINER HOOK IS INSTALLED PROPERLY. ALL SIMULATED SCENARIOS REQUIRE IMPROPERLY INSTALLED CARABINER IN THE REACHER OR THE STRAP IN THE CARABINER, IN ORDER TO APPLY A FORCE WHICH CAUSES THE OPENING THE CARABINER LATCH. IT SHOULD BE NOTED THAT IT IS CRUCIAL TO FOLLOW ALL SAFETY INSTRUCTIONS REGARDING DEVICE ATTACHMENT ON A TRACK, INCLUDED IN THE DEVICE LABELLING TO PROVIDE AN EASY AND SAFE INSTALLATION AND USAGE OF CEILING LIFT DEVICES. MAXI SKY 440 INSTRUCTIONS FOR USE (001.16000.33 REV.13) PRESENTS STEP BY STEP TRANSFER PROCEDURE. IT ALSO STATES THAT THE DAILY MAINTENANCE SHOULD BE CARRIED OUT BEFORE USING THE LIFT: "INSPECT THE CARABINER AT THE TOP OF THE STRAP TO ENSURE THAT IT IS PROPERLY ATTACHED." THE IFU OF THE REACHER (001.08315, REV. 5) ALSO SHOWS THE ADEQUATE WAY TO INSTALL THE CARABINER IN THE REACHER, WHAT IS ESSENTIAL TO PROVIDE SAFE AND EFFICIENT TRANSFER. TAKING INTO CONSIDERATION CUSTOMER'S OPINION AND THE FACT THAT NO TECHNICAL DEFICIENCY OF THE LIFTING SYSTEM WAS FOUND, THE MOST LIKELY ROOT CAUSE SEEMS TO BE INCORRECT PREPARATION OF THE CEILING LIFTING SYSTEM FOR USE. IN SUMMARY, THE CEILING LIFT CARABINER DETACHED FROM THE STRAP AND FROM THAT PERSPECTIVE, DEVICE DID NOT PERFORM AS INTENDED. THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED INCIDENT. THERE WAS NO PHYSICAL INJURY OR DAMAGE TO THE HEALTH OF PEOPLE.

    Description of Event or Problem · 0

    ON (B)(6) 2019 ARJO WAS INFORMED ABOUT INCIDENT THAT TOOK PLACE ON MAXI SKY 440 CEILING LIFT. IT WAS REPORTED THAT DURING TRANSFER FROM BED TO CHAIR, WHEN THE RESIDENT WAS BEING LIFTED UP FOR A FEW CENTIMETERS, THE MAXI SKY FELL TOGETHER WITH THE RESIDENT TO THE BED. NO INJURY WAS SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268556 MAXI SKY 440 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. LE00000-EUUK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other