MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 440; LIFT, PATIENT, NON-AC-POWERED

Model Number LE00000

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Installation-Related Problem (2965)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Arjohuntleigh representative was nominated to obtain more information related to the incident.Additional information will be provided upon conclusions of the investigation.

Event Description

On (b)(4) 2017, arjohuntleigh received an information about the incident which occurred on (b)(6) 2017.The issue was related to easytrack system (portable installation dedicated for portable ceiling lift).It was reported that the one of the 2 posts supporting the track collapsed while the resident was being transferred by the caregiver from his bed to his powered wheelchair.The resident suffered a double fracture of his left femur.Medical intervention (hospitalization) was needed.

Manufacturer Narrative

Arjohuntleigh received the customer complaint with the involvement of the maxi sky 440 (portable ceiling lift) attached on the 2-post assembly easytrack system (portable installation).It was reported that the one of the two posts supporting the track collapsed.It occurred while the resident was being transferred by his caregiver from his bed to his powered wheelchair.As a consequence of the event , the resident fall down and suffered a double fracture of his left femur and required medical intervention.When reviewing similar reportable events registered during last 5 years (sep 2012 up to oct 2017), we have found a few cases that may relate to the issue investigated here: unstable easytrack system.It should be emphasized, that the easytrack is a floor to ceiling pressure fit system, not requiring a permanent installation to the structure of the room.It is 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 (swl) of 200 kg.The instruction how prepare the system to use is described step by step in the instruction for use (ifu 001.10600.En, rev.12) which is delivered with each portable installation.If the user follows every guideline given in the ifu, there is a very low possibility of any potentially risky situation to occur.Based on information collected from the customer facility delegate by arjohuntleigh representative, the one from easytrack posts fell causing the whole installation became unstable and collapsed.We (arjohuntleigh) are not able to excluded a technical malfunction as potential cause of this incident because during the inspection of the involved system a slight damaged on the upright post and on hook on one side of the rail was observed.It is unknown if this occurred when the system collapsed or it was broken before the incident.According to the ifu, the caregiver is obligated (before every use) to perform inspection according to following points: "carefully inspect all the components.If any pieces are missing or appear damaged - do not assemble.Contact your local arjohuntleigh agent for further instructions.Ensure all components are in working order.Ensure that the extendable track cannot be extended beyond the red marks.Ensure that the holes on both sides of every posts are not flared du to wearing and that the pins are in good working order.Using the clip-on level, make sure that all posts are straight.If any post is not straight remove the extendable track and level post accordingly.Red mark on top of each post (under the top plate) is not visible.The extendable track is secured in place.Press up on the track to make sure that it is locked onto the post." it should be emphasized, that the customer was not able to confirm if the system was checked before the use.In light of this information we are not able to confirm if the posts were sufficiently supported and correctly locked in the positions as per user ifu.In this case the root cause was very hard to define despite the analysis of all collected information.Following the preventive maintenance checks described in the ifu allow to detect the failed components and avoid any incidents.In conclusion, the system was being used with a resident at the time of the event and played a role in the reported incident.Following the above findings, the system was unstable so it was not up to its manufacturer's specifications during the incident.We find this complaint to be reportable to the competent authority because the adverse event occurred.

• Brand Name: MAXI SKY 440
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6844277
• MDR Text Key: 84939750
• Report Number: 9681684-2017-00069
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: LE00000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2017
• Distributor Facility Aware Date: 08/30/2017
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 10/18/2017
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 95