BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER PORTABLE

    MDR report key: 8494775 · Received April 9, 2019

    Report

    Report Number
    9681684-2019-00034
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2019-MAR-11 ARJO WAS INFORMED ABOUT AN INCIDENT RELATED TO VOYAGER PORTABLE CEILING LIFT ATTACHED TO EASYTRACK PORTABLE INSTALLATION. IT WAS REPORTED THAT THE TOP RAIL OF THE INSTALLATION FELL TO THE RESIDENT DURING USE, FORTUNATELY WITHOUT CAUSING ANY INJURY. WHEN REVIEWING SIMILAR REPORTABLE EVENTS ON EASYTRACK SYSTEM REGISTERED DURING THE LAST 5 YEARS, A LOW NUMBER OF CASES THAT MAY RELATE TO THE COLLAPSED EASYTRACK SYSTEM WERE FOUND. THE INSTALLATION INVOLVED IN THE EVENT WAS EASYTRACK PORTABLE SYSTEM WITH A MODEL NUMBER 9220010, DURING THE EVENT USED WITH VOYAGER CEILING LIFT (MODEL NUMBER 9800009, SERIAL NUMBER (B)(4)). THE SYSTEM WAS MANUFACTURED BY ARJOHUNTLEIGH MAGOG (CANADA). FOLLOWING PROVIDED INFORMATION, THE SYSTEM WAS INSTALLED BY A THIRD PARTY COMPANY ON 2019-MAR-07, AND THE EVENT TOOK PLACE A DAY LATER ON (B)(6) 2019. THE THIRD PARTY COMPANY REPRESENTATIVE HAS VISITED THE CUSTOMER HOME FOR DEVICE INSPECTION AND NOTICED THE HOOKS THAT HOLD THE RAIL TO THE POST WERE DEFLECTED, HOWEVER IT IS UNKNOWN IF THE VISIBLE DEFLECTION WAS PRESENT BEFORE EVENT OR RATHER WAS CREATED BY FALLING RAIL. EASYTRACK SYSTEM 2-POST ASSEMBLY INSTRUCTIONS FOR USE (DOCUMENT NUMBER 001.10600.EN REV. 12 DATED ON MARCH 2014) WHICH IS DELIVERED WITH EACH PORTABLE INSTALLATION, GIVE STEP BY STEP GUIDELINES HOW TO ASSMEBLY THE INSTALLATION PRIOR USE. "WARNING: PROCEED WITH THE INSPECTION OF THE EASYTRACK SYSTEM BEFORE INSTALLING. REFER TO "CARE AND MAINTENANCE" ON PAGE 12. FAILURE TO DO SO MAY LEAD TO INJURY." "BEFORE INSTALLING: CAREFULLY INSPECT ALL THE COMPONENTS. IF ANY PIECES ARE MISSING OR APPEAR DAMAGED - DO NOT ASSEMBLE. CONTACT YOUR LOCAL ARJOHUNTLEIGH AGENT FOR FURTHER INSTRUCTIONS." IF THE USER FOLLOWS EVERY GUIDELINE GIVEN IN THE IFU, THERE IS A VERY LOW POSSIBILITY OF ANY POTENTIALLY RISKY SITUATION TO OCCUR. TAKING INTO CONSIDERATION THAT THIS WAS THE FIRST USE OF THE SYSTEM, THE MOST LIKELY ROOT CAUSE SEEMS TO BE INCORRECT PREPARATION OF THE INSTALLATION FOR USE. THE EASYTRACK PORTABLE SYSTEM WAS BEING USED WITH A PATIENT AT THE TIME OF THE EVENT AND PLAYED A ROLE IN THE REPORTED EVENT. THERE WAS A TECHNICAL DEFICIENCY FOUND WITHIN THE DEVICE, HOWEVER IT IS UNKNOWN IF IT WAS A CAUSE OR EFFECT OF THE EVENT. NO SERIOUS INJURY OCCURRED.

    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). FOLLOWING PROVIDED INFORMATION, THE SYSTEM WAS INSTALLED BY A THIRD PARTY COMPANY ON (B)(6) 2019, AND THE EVENT TOOK PLACE A DAY LATER, WHILE THE RESIDENT CAME BACK FROM THE HOSPITAL. THE THIRD PARTY COMPANY REPRESENTATIVE HAS VISITED THE CUSTOMER HOME TO INSPECT AND NOTICED THE HOOKS THAT HOLD THE RAIL TO THE POST WERE DAMAGED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSIONS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2019 ARJO WAS INFORMED ABOUT AN INCIDENT RELATED TO VOYAGER PORTABLE CEILING LIFT ATTACHED TO EASYTRACK PORTABLE INSTALLATION. IT WAS REPORTED THAT THE TOP RAIL OF THE INSTALLATION FELL WHILE LIFTING THE RESIDENT. THE RESIDENT DID NOT SUSTAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291177 VOYAGER PORTABLE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. 9800009

    Patients

    Seq Age Sex Outcome Treatment
    1 Other