BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER

    MDR report key: 2497970 · Received March 8, 2012

    Report

    Report Number
    9681684-2012-00027
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 4, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). (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. THERE IS A TREND OF LESS THAN (B)(4) SIMILAR EVENTS IN AVERAGE BY YEAR, SO THE OCCURRENCE RATE APPEARS TO BE VERY LOW WHEN COMPARED TO THE ESTIMATED 15,000 INSTALLED BASES OF SIMILAR DEVICES ON THE WORLDWIDE MARKET. THE PROBLEM WAS FOUND TO BE RELATED TO THE POSTS SYSTEM, NOT THE PORTABLE CEILING LIFT. NO RELEVANT INFO WAS FOUND WHEN REVIEWING THE MFG PROCESS AND THE HISTORY OF THE POSTS SYSTEM. AN ON-SITE INSPECTION WAS PERFORMED BY AN ARJOHUNTLEIGH REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION. THIS TOOK PLACE AFTER A THIRD PARTY HAD INSPECTED/RE-INSTALLED THE EASYTRACK (MODEL #9220010) SYSTEM. THE ARJOHUNTLEIGH INVESTIGATOR NOTICED THAT THE LEFT SUPPORT POST OF THE SYSTEM WAS REPOSITIONED FURTHER AWAY FROM THE BED AND RETIGHTENED AGAINST THE CEILING. THE DISTANCE BETWEEN THE BED AND POST WAS INITIALLY 750 MM AND WAS APPROX 960 MM WHEN HE INSPECTED IT. THE FACILITY PROVIDED ITS INTERNAL REPORT, WHICH PERMIT TO GATHER THE FOLLOWING FACTS: THE BED HAS BEEN REPLACED THE PREVIOUS DAY BEFORE THE EVENT. THE CAREGIVERS NOTICED THAT DUE TO THE NEW BED, THERE WAS NOT AS MUCH ROOM AS BEFORE TO PERFORM THE TRANSFER. PERSONNEL INVOLVED IN MOVING THE BED AND FURNITURE AFFIRMED THEY DID NOT HIT THE POSTS, BUT THEY NOTICED, DUE TO THE NEW BED THAT WAS WIDER, THAT THE AREA AVAILABLE FOR THE TRANSFERS WAS REDUCED. THEY CONTACTED THE SERVICE PROVIDER FOR THE INSTALLATION TO BE WIDENER TO ACCOMMODATE THE NEW BED, BUT THE SERVICE PROVIDER WAS UNAVAILABLE AT THAT TIME. THE HEALTH & SAFETY EXECUTIVE FOR (B)(4) WAS CONTACTED AND DID NOT DETECT ANY DEFECT OR FAILURE WITH THE CEILING LIFT SYSTEM, SO IT WAS FELT THE EVENT WAS CAUSED BY A USER ERROR. PICTURES PROVIDED TO THE MFR SHOW NUMEROUS SCRATCHES AROUND THE POST, MOST LIKELY CAUSED BY IMPACTS. SINCE THE EVENT DESCRIPTION, INFO FROM ON-SITE VISIT AND INFO FROM THE CUSTOMER INVESTIGATION WAS SUFFICIENT TO PROCEED WITH THE INVESTIGATION, NO PRODUCT RETURN AND SIMULATION WAS DEEMED NECESSARY. THIS TYPE OF INSTALLATION IS A FLOOR TO CEILING PRESSURE SYSTEM, REQUIRING NO PERMANENT INSTALLATION TO THE STRUCTURE OF THE ROOM, SECURED WITH A SPRING LOADED PRESSURE MECHANISM LOCATED IN THE POST. AS LONG AS THE PRESSURE IS PRESENT BETWEEN THE FLOOR AND CEILING, THE SYSTEM WILL BE SAFE TO USE UP TO ITS SAFE WORKING LOAD OF 440 LB. THE ABSENCE OF PRESSURE WILL RESULT IN RED AREA AT THE TOP OF THE POSTS BEING VISIBLE AND BASED ON THE INFO RECEIVED, IT IS EVALUATED THAT ONE OF THE POSTS OF THE SYSTEM TIPPED FORWARD BECAUSE THERE WAS INSUFFICIENT PRESSURE IN IT TO SUPPORT THE PT WEIGHT. IT IS KNOWN FROM THE RISK ANALYSIS AND DESIGN TESTING THAT THE SYSTEM CAN TOLERATE AN INSTALLATION OF A POST AT AN ANGLE UP TO A CERTAIN LIMIT. A LEVELER WHICH CAN BE ATTACHED TO THE POST IS DELIVERED WITH THE SYSTEM, SO THAT THE USER CAN INSTALL HIS POSTS VERTICALLY WITH LITTLE OR NO ANGLE. THE BED REPLACEMENT PERFORMED IN THE ROOM THE DAY PREVIOUS THE EVENT CAUSED THE SPACE AVAILABLE TO POSITION THE WHEELCHAIR FOR PT TRANSFER TO BE REDUCED TO APPROX 750 MM (29.5IN), WHICH IS LESS THAN THE 915 MM (36 IN) OF WORKING SPACE REQUIRED AS PER THE EASYTRACK INSTRUCTIONS FOR USE (001.10600 REV 8). THIS MINIMUM WORKING SPACE REDUCES THE RISK OF ACCIDENTALLY BUMPING THE POST SYSTEM WHILE TRANSFERRING A PT TO A WHEELCHAIR. THE POST WHICH MALFUNCTIONED DURING USE WAS THE ONE NEXT TO THE WHEELCHAIR. BASED ON THE FACTS GATHERED, IT IS CONCLUDED THAT THE EVENT OCCURRED MOST LIKELY BECAUSE THE POST WAS IMPACTED DUE TO THE REDUCED WORKING SPACE. IT IS CONSIDERED THAT KNOWLEDGE OF THE DEVICE LABELING WOULD HAVE PERMITTED TO AVOID THIS EVENT, AND IT IS THEREFORE CONCLUDED THAT A POSSIBLE LACK OF TRAINING LED TO THIS EVENT. AS MENTIONED IN THE INSTRUCTIONS FOR USE OF THE EASYTRACK 2 POSTS SYSTEM (001.10600 REV 8): "ALLOW 36 INCHES OPEN AREA FOR TRANSFER WORKING SPACE (P.10)", WHICH IS ALSO REPRESENTED BY A DIAGRAM. "DO NOT HIT POSTS - THIS MIGHT CAUSE UNIT TO BECOME UNSTABLE. IF POSTS ARE HIT, REASSEMBLE THE EASYTRACK SYSTEM TO ENSURE THE POSTS ARE STRAIGHT (P.9)". "BEFORE EACH TIME YOU USE THE EASYTRACK SYSTEM, VISUALLY INSPECT THE EASYTRACK SYSTEM TO MAKE SURE: THAT POSTS ARE STRAIGHT. IF THEY DO NOT APPEAR STRAIGHT, USE LEVEL TO CHECK. IF POSTS ARE NOT STRAIGHT, REMOVE RAIL AND RE-INSTALL POST. RED ZONE ON TOP OF POST IS NOT VISIBLE (P.20)." THE MFR CONSIDERS THIS MISUSE TO BE CLEARLY WARNED AGAINST IN THE DEVICE LABELING. IT IS RECOMMENDED THAT THE PERSONNEL AT THE FACILITY BE RETRAINED ON THE INSTRUCTIONS FOR USE OF THE 2-POSTS EASYTRACK SYSTEM (001.10600 REV 8), ESPECIALLY ON THE PRECAUTIONS REGARDING THE USE OF THE DEVICE AND ON THE VERIFICATIONS REQUIRED TO BE PERFORMED BEFORE EACH TIME THE EASYTRACK SYSTEM IS USED.

    Description of Event or Problem · 1

    THE CAREGIVERS WERE TRANSFERRING THE RESIDENT FROM HER BED TO THE WHEELCHAIR USING A PORTABLE CEILING LIFT INSTALLED IN AN EASYTRACK SYSTEM. WHILE THEY WERE OVER THE WHEELCHAIR, THE LEFT POST OF THE EASYTRACK FELL FORWARD CAUSING THE RESIDENT TO FALL ONTO THE SIDE OF THE WHEELCHAIR. THE CAREGIVERS REACHED OUT TO GRAB THE SLING STRAPS TO PREVENT RESIDENT FALLING. IT WAS REPORTED THAT THE HANDSET GLANCED THE FACE OF THE RESIDENT BUT SHE DID NOT SUSTAIN ANY INJURIES. ONE OF THE CAREGIVERS HURT HER BACK BUT NO DETAILS ABOUT THE SEVERITY OR TREATMENT WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER MANUFACTURED PORTABLE CASSETTES FSA ARJOHUNTLEIGH MAGOG 9800008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other