BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER

    MDR report key: 2481733 · Received March 2, 2012

    Report

    Report Number
    9681684-2012-00021
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 7, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG
    Product Code
    FNG
    Removal / Correction Number
    Z-0482-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ((B)(4)) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). A COMPLETE INVESTIGATION WAS PERFORMED BY THE MFR, INCLUDING A REVIEW OF THE TREND OF SIMILAR PROBLEM, HISTORY OF THE PRODUCT INVOLVED AND TEST REPORT AVAILABLE ABOUT THIS TYPE OF PRODUCT AND FAILURE MODE. THERE IS A TREND OF (B)(4) EVENT IN AVERAGE BY YEAR, SO THE OCCURRENCE RATE APPEARS TO BE VERY LOW WHEN COMPARED TO THE NUMBER OF TRANSFER DAILY PERFORMED WITH THE ESTIMATED (B)(4) INSTALLED BASES OF SIMILAR DEVICES ON THE WORLDWIDE MARKET. FROM THIS TREND REVIEW, IT MUST ALSO BE NOTED THAT (B)(4) EVENTS OCCURRED AT THE SAME FACILITY IN THE SAME PERIOD OF TIME. NO RELEVANT INFO WAS FOUND WHEN REVIEWING THE MFG PROCESS. THERE HAS BEEN A FIELD ACTION (FDA REFERENCE #Z-0482-2007) TO INFORM CUSTOMER OF THE POTENTIAL RISK THAT FASTENING THE CARABINEER TO THE EXTERIOR OF THE CLOSED RING PORTION OF THE REACHER IS CONTRARY TO THE MANUFACTURER'S INSTRUCTIONS AND IS AN UNSAFE PRACTICE. THIS CUSTOMER HAS BEEN REACHED DURING THE FIELD ACTION. AN ON-SITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH REPRESENTATIVE (A REPRESENTATIVE OF THE MANUFACTURER'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR). THE PORTABLE CEILING LIFT WAS FOUND IN GOOD WORKING CONDITION, WITH MINOR SCRATCHES AND WEAR. CLEAR PICTURES WERE RECEIVED BY THE MFR, WHICH CONFIRM THE OBSERVATIONS OF THE REPRESENTATIVE. THE REACHER, THE CARABINEER AND THE TROLLEY OF THE PORTABLE CEILING LIFT DID NOT PRESENT ANY DAMAGES. IT WAS NOT POSSIBLE TO RECREATE THE FAILURE MODE ON-SITE. SINCE THE COMPLAINT INFO WAS SUFFICIENT TO EXPLAIN THE EVENT, NO PRODUCT RETURN WAS DEEMED NECESSARY. AN INTERNAL SIMULATION WAS PERFORMED AT THE MFG SITE IN ORDER TO REPRODUCE THE FAILURE MODE. IT WAS REPORTED IN THE COMPLAINT THAT THE PT WAS MOVED LATERALLY BEFORE THE PORTABLE CEILING LIFT FELL, WHICH MEANS THAT THE CARABINEER WAS INSTALLED IN A WAY WHICH SHOULD ALLOW THE WEIGHT TO BE SUPPORTED FOR A CERTAIN PERIOD OF TIME BEFORE FALLING FROM THE CEILING LIFT. ONLY ONE OF THE POSSIBILITIES ASSESSED WAS FOUND PLAUSIBLE TO EXPLAIN THE EVENT, SINCE THE OTHER WILL RESULT IN THE IMMEDIATE FALL OF THE PORTABLE CEILING LIFT, BEFORE THE WEIGHT OF THE PT IS SUPPORTED IN THE LIFT. THIS SITUATION INVOLVES INSTALLING THE CARABINEER AT THE TOP OF THE REACHER LOOP, INSTEAD OF HAVING IT RESTING AT THE BOTTOM OF THE REACHER LOOP AS INTENDED. THIS POSSIBILITY IS CONSIDERED AS A USER ERROR SINCE THE INSTRUCTIONS FOR USE OF BOTH THE REACHER AND THE CEILING LIFT SHOWS HOW TO INSTALL THE CARABINEER. FURTHERMORE, A WARNING STICKER ON THE REACHER, PROVIDED DURING THE FIELD ACTION, SHOWS HOW TO PROPERLY ATTACH THE CARABINEER TO THE REACHER. BASED ON THE INFO AVAILABLE AND SIMULATION PERFORMED, IT IS CONCLUDED THAT THE CARABINEER WAS NOT PROPERLY INSTALLED SINCE THE CAREGIVER DID NOT PROPERLY FOLLOW THE INDICATIONS PROVIDED IN THE VOYAGER INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE OF THE VOYAGER (001.08075 REV 7) CLEARLY STATES THAT PRIOR TO EACH USE, THE CAREGIVER SHOULD: "INSPECT THE HOOK AT THE TOP OF THE STRAP TO ENSURE THAT IT IS PROPERLY ATTACHED (P. 59)." THIS WOULD HAVE PREVENTED THE USER FROM ATTEMPTING A TRANSFER IF THE CARABINEER AND STRAP WERE NOT INSTALLED PROPERLY. MOREOVER, THE INSTRUCTIONS FOR USE OF THE REACHER (001.08315 REV 2) ALSO PRESENT THE ADEQUATE WAY TO INSTALL THE CARABINEER IN THE REACHER, AND THE REACHER IN THE CEILING LIFT TROLLEY. IT ALSO PRESENTS THE POTENTIAL USER ERRORS WITH THE CARABINEER. THIS SHOULD PREVENT THE USER FROM ATTEMPTING A TRANSFER IF THE LIFT REACHER AND CARABINEER ARE NOT PROPERLY INSTALLED. IT IS RECOMMENDED TO THE CUSTOMER TO RETRAIN THE PERSONNEL THAT OPERATE THIS TYPE OF ACCESSORY AND RECORD THIS RETRAINING, ESPECIALLY ABOUT THE IFU RECOMMENDATIONS MENTIONED ABOVE.

    Description of Event or Problem · 1

    THE CAREGIVER WAS IN PROCESS OF A RESIDENT TRANSFER FROM WHEELCHAIR TO BED USING A VOYAGER PORTABLE CEILING LIFT SECURED TO THE TROLLEY IN THE TRACK BY A CARABINEER FIXED TO A REACHER. THE RESIDENT WAS RAISED, MOVED OVER THE BED, LOWERED ABOUT 1 OR 2 INCHES OFF OF THE BED WHEN THE LIFT DISCONNECTED FROM THE REACHER BAR FALLING DOWN, HITTING THE RESIDENT ON THE RIGHT HAND. THE REACHER BAR REMAINED ON THE TROLLEY AND THE CARABINEER CAME DOWN WITH THE LIFT, STILL ATTACHED TO THE LIFTING STRAP. THE RESIDENT SUSTAINED A MINOR SCRATCH TO THE RIGHT HAND, WHICH DID NOT REQUIRE ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER MANUFACTURED PORTABLE CASSETTES FNG ARJOHUNTLEIGH MAGOG VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other