VOYAGER PORTABLE
Report
- Report Number
- 9681684-2019-00032
- Event Type
- Malfunction
- Date Received
- April 4, 2019
- Report Date
- September 24, 2019
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
PRODUCT RETURN FOR EVALUATION IS BEING ORGANIZED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSIONS OF THE INVESTIGATION.
ON 2019-MAR-06 ARJO WAS MADE AWARE OF AN INCIDENT RELATED TO EASYTRACK INSTALLATION USED WITH VOYAGER CEILING LIFT. IT WAS REPORTED THAT THE INSTALLATION COLLAPSED WHILE LIFTING THE RESIDENT. THERE WERE NO INJURIES BUT AN AMBULANCE HAD BEEN CALLED. STATISTICAL ANALYSIS OF THE REPORTABLE EVENTS REGISTERED DURING THE LAST 5 YEARS REVEALED NO TREND RELATED TO SITUATIONS WHERE EASYTRACK SYSTEM COLLAPSES DURING THE RESIDENT TRANSFER. THE INSTALLATION INVOLVED IN THE EVENT WAS EASYTRACK PORTABLE SYSTEM WITH A MODEL NUMBER 9220010, USED WITH VOYAGER PORTABLE CEILING LIFT (MODEL NUMBER 9225010, SERIAL NUMBER (B)(6)). THE SYSTEM WAS MANUFACTURED BY ARJOHUNTLEIGH MAGOG (CANADA). THIS SYSTEM CONSISTS OF THE EXTENDABLE TRACK SUPPORTED BY TWO POSTS, ALSO EXTENDABLE. EACH POST STAND ON THE FOOT PLATE AND IS WEDGED WITH A CEILING PLATE, TO PERSIST STABILITY. ADDITIONALLY, THE FOOT AND CEILING PLATES ARE EQUIPPED WITH NEOPRENE PADDINGS IN ORDER TO PREVENT THE INSTALLATION RAILS FROM SLIPPING. FOLLOWING INFORMATION PROVIDED, THE INSTALLATION WAS PERFORMED BY A THIRD PARTY COMPANY AND HAD FAILED A FEW DAYS LATER. PHOTOGRAPHIC DOCUMENTATION WAS PROVIDED AND SHOWED THE INSTALLATION CONDITION AFTER THE EVENT AS WELL AS ENVIRONMENT WHERE IT WAS INSTALLED. PICTURES CLEARLY SHOW POOR CONDITION OF THE ROOM (INCLUDING SUSPENDED CEILING MADE OF CARDBOARD TILES, WITH A WATER MARKS, BROKEN CERAMIC PUT ON LINOLEUM, UNCLEANED AREA AND HOLE IN THE WALL/FLOOR). THE EASYTRACK WAS RETURNED TO MANUFACTURER FOR FURTHER TECHNICAL INVESTIGATION. BASED ON THOROUGH PARTS EVALUATION AS WELL AS REVIEW OF THE PHOTOS PROVIDED, TWO CONTRIBUTING FACTORS HAVE BEEN IDENTIFIED: 1. USING THE UNAUTHORIZED COMPONENTS - FOOT PADDINGS: THE VISUAL INSPECTION REVEALED THAT THE FOOT PADDINGS INSTALLED AT THE INVOLVED FOOT PLATES WERE NOT AN ARJO PARTS. ITS ADHERENCE AND ANOTHER TECHNICAL PARAMETERS ARE UNKNOWN. EASYTRACK SYSTEM 2-POST ASSEMBLY INSTRUCTIONS FOR USE (IFU, DOCUMENT NUMBER 001.10600.EN REV. 12 DATED ON MARCH 2014) WHICH IS DELIVERED WITH EACH PORTABLE INSTALLATION, GIVE GUIDELINES HOW TO CHECK THE INSTALLATION BEFORE EVERY USE: "WARNING: ARJOHUNTLEIGH STRONGLY ADVISES AND WARNS THAT TO AVOID INJURIES THAT CAN BE ATTRIBUTED TO THE USE OF INADEQUATE PARTS, ONLY PARTS DESIGNATED BY ARJOHUNTLEIGH SHOULD BE USED ON PRODUCT AND OTHER APPLIANCES SUPPLIED BY ARJOHUNTLEIGH.[...] CAREFULLY INSPECT ALL THE COMPONENTS. IF ANY PIECES ARE MISSING OR APPEAR DAMAGED - DO NOT ASSEMBLE. CONTACT YOUR LOCAL ARJOHUNTLEIGH AGENT FOR FURTHER INSTRUCTIONS. [...] MAKE SURE THE PADDING ON THE FOOT AND TOP PLATE IS CLEAR OF ANY FOREIGN SUBSTANCE AND IS NOT DAMAGED. HAVE THE PADDINGS REPLACED ACCORDINGLY." 2. INADEQUATE ROOM CONDITIONS: THERE ARE CERTAIN REQUIREMENTS FOR THE EASYTRACK SYSTEM TO SUSTAIN SAFETY OF THE INSTALLATION. AS FOR THE CEILING REQUIREMENTS, THE IFU INDICATES THAT: "THE EASYTRACK MUST BE INSTALLED TO A RIGID CEILING WHICH HAVE A FRAMEWORK ABOVE IT. [...] CEILING STRUCTURE MUST HAVE A MAXIMUM OF 610 MM (24 ") BETWEEN THE TRUSSES OR JOISTS. [...] CEILING MUST BE MADE OF WOOD OR 12.7 MM (1/2 ") SHEET ROCK OR THICKER. [...] CEILING MUST BE CLEAR OF ANY DUST, GREASE, WATER OR ANY FOREIGN SUBSTANCE." AS FOR THE FLOOR REQUIREMENTS, THE IFU INDICATES THAT: "FLOORING MUST COMPLY TO LOCAL BUILDING CODE STANDARDS. [...] FLOOR MUST BE CLEAR OF ANY DUST, GREASE, WATER OR ANY FOREIGN SUBSTANCE." THE EVALUATION OF THE SYSTEM REQUIREMENTS AT CUSTOMER'S PLACE AS PER THE PICTURES AND THE INFORMATION PROVIDED IN THE COMPLAINT INDICATED THAT THOSE FOR THE CEILING WERE NOT MET. IT WAS NOT POSSIBLE TO CONFIRM IF THE FLOOR REQUIREMENTS WERE MET OR NOT, BUT THE PICTURES INDICATED THAT THE GENERAL ENVIRONMENT COULD HAVE CONTRIBUTED TO LACK OF PROPER INSTALLATION STABILITY. TO SUM UP, THE MOST LIKELY ROOT CAUSE SEEMS TO BE USING NOT AUTHORIZED SPARE PARTS (FOOT PADDINGS) IN COMBINATION WITH NOT FOLLOWING DEVICE LABELLING IN REGARDS TO EASYTRACK SYSTEM REQUIREMENTS TOWARDS CEILING AND FLOOR SPECIFICATION. THE EASYTRACK PORTABLE CEILING LIFTING SYSTEM WAS BEING USED WITH A PATIENT AT THE TIME OF THE EVENT AND BY THIS PLAYED A ROLE IN THE REPORTED EVENT. THERE WAS A TECHNICAL DEFICIENCY FOUND WITHIN THE INSTALLATION RAIL SYSTEM. NO SERIOUS INJURY OCCURRED.
ADDITIONAL CLARIFICATION WITH THE (B)(4), A THIRD PARTY DEVICE DISTRIBUTOR, WAS PROVIDED. WHEN THE DISTRIBUTOR ARRIVED TO THE COMPLAINANT'S RESIDENCE, FOUND THE EASYTRACK SYSTEM DISMANTLED, LYING OUTSIDE THE BUILDING IN THE DIRT. THE SYSTEM WAS THEN ASSEMBLED IN THE ROOM WHERE THE ALLEGED INCIDENT TOOK PLACE AND LOAD TEST WAS PERFORMED. NO MOVEMENT OF THE TRACK WAS DETECTED. ALSO NO MARKS OF THE INSTALLATION FALLING WERE FOUND ON THE CEILING, WALLS OR THE FLOOR. THE DEVICE DISTRIBUTOR SUPPOSED THAT NO INSTALLATION COLLAPSE TOOK PLACE AND THE DAMAGE OF THE RAIL WAS CAUSED BY TAMPERING. ANALYSIS OF THE RETURNED PARTS AND PROVIDED PHOTOS INDICATED THAT NON-AUTHORIZED SPARE PARTS (FOOT PADDINGS) WERE USED AND CEILING SPECIFICATION IN REGARDS TO EASYTRACK SYSTEM REQUIREMENTS MIGHT NOT BE FOLLOWED. ON THE OTHER HAND, THE DEVICE DISTRIBUTOR ALSO SUPPOSES THAT NO INSTALLATION COLLAPSE TOOK PLACE AND THE DAMAGE OF THE RAIL WAS CAUSED BY TAMPERING. BASED ON THE ABOVE, THE ROOT CAUSE COULD NOT BE STATED WITH A CERTAINTY. THE EASYTRACK PORTABLE CEILING LIFTING SYSTEM WAS BEING USED WITH A PATIENT AT THE TIME OF THE EVENT AND BY THIS PLAYED A ROLE IN THE REPORTED EVENT. THERE WAS A TECHNICAL DEFICIENCY FOUND WITHIN THE INSTALLATION RAIL SYSTEM. NO SERIOUS INJURY OCCURRED.
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.
ON (B)(6) 2019 ARJO WAS MADE AWARE OF AN INCIDENT CONCERNING EASYTRACK INSTALLATION USED WITH VOYAGER CEILING LIFT. IT WAS REPORTED THAT THE SYSTEM COLLAPSED AND STRUCK THE PATIENT. THERE WERE NO INJURIES BUT AN AMBULANCE HAD BEEN CALLED. THE END-USER IS ALLEGING THAT THE INSTALLATION WAS IMPROPER. THE HOME CARE DEALER, A THIRD PARTY COMPANY, COMPLETED AN INVESTIGATION AND CONCLUDED THAT THE INSTALLATION WAS PROPERLY DONE. DURING THEIR INVESTIGATION, IT WAS NOTED THAT WAS NO EVIDENCE OF A FAILURE AS THERE WERE NO SURFACE MARKINGS THAT WOULD INDICATE THE LIFT HAD FAILED ON ITS' OWN. THEIR OPINION IS THAT THE CLIENTS HAD TRIED TO MOVE THE LIFT WHEN IT FELL. THE DEALER MENTIONED THERE MAY HAVE BEEN OTHER CIRCUMSTANCES AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278709 | VOYAGER PORTABLE | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJOHUNTLEIGH MAGOG INC. | 9220010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |