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

Model Number KMCSAN

Device Problems Use of Device Problem (1670); Device Damaged Prior to Use (2284)

Patient Problems Fall (1848); Skin Tears (2516); No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar events for the maxi move passive floor lift it has been found one similar case where a person tripped over one of the legs of the device.No complaint trend for this failure mode exists.With the number of sold devices and comparison to daily use of a device, we find occurrence rate of this failure on the market since march 2012 to be very low.It was reported to arjohuntleigh that a caregiver, while trying to get the maxi move passive floor lift to transfer a resident, stepped over the device legs and her foot stuck under damaged leg's cover.She fell on the left knee.The cover got loose from the earlier damaged part of the lift.It cannot be established with certainty how this part got damaged before the incident, however it is very likely that customer negligence or rough handling of the device (e.G.Hitting the chassis legs against bedframes, walls or furniture) had caused this failure.After the event, the caregiver stud up and completed the resident transfer onto a bed.As a consequence of this incident, the caregiver has sustained a small tear in her knee treated with a bandage for extra support.She continued her duties without taking a sick leave.The described injury was not assessed a serious one by clinical expert.The hoist was put through a function and visual test by the arjohuntleigh representative that visited the customer site.The damaged leg covers were removed and replaced.The lift was returned to use in good working conditions.In course of the manufacturer's investigation it was tried to establish a root cause of the issue that occurred.It was confirmed that the covers of the chassis legs were damaged with protruded sharp edges.It is highly probable that the caregiver was not enough careful during usage of the device, hook her foot against the leg cover while stepping it over and fell as a misadventure.The maxi move instruction for use delivered with each sold device informs the user: "mandatory daily checks: the following checks should be carried out daily: "carefully inspect all parts, in particular where there is close contact with the patient's body.Ensure that no cracks or sharp edges have developed which could injure the patient's skin or become unhygienic.Check that all external fittings are secure and that all screws and nuts are tight.(.)warning: if in doubt about the correct functioning of the maxi move, do not use it and contact the arjohuntleigh service department".It is assumed that if the user had followed the instructions provided by the manufacturer and replaced the damaged covers with new ones, the risk associated with the event that occurred could have been avoided.From these findings, the device played a role in the reportable event while it was being used with a patient - not due to a malfunction as was suggested but due to the customer / user not following the instructions for use which put the caregiver in the risky situation.If the ifu and the correct transferring procedure had been followed with using adequate precautions, the event would have been avoided.

Event Description

It was reported to arjohuntleigh that a caregiver, while trying to get the maxi move passive floor lift to transfer a resident, step over the device legs and her foot stuck under damaged leg's cover.She fell with her knee on the next leg.The cover got loose from the earlier damaged part of the lift.It cannot be established with certainty how this part got damaged before the incident, however it is very likely that customer negligence or rough handling of the device (e.G.Hitting the chassis legs against bedframes, walls or furniture) had caused this failure.After this event, the caregiver stud up and completed the resident transfer onto a bed.As a consequence of this incident, the caregiver has sustained a small tear in her knee treated with a bandage for extra support.She continued her duties without taking a sick leave.The described injury was not assessed a serious one by clinical expert.It was confirmed that the damaged leg covers were removed and the lift is back in good working conditions.

• Brand Name: MAXI MOVE
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, ; CA
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 698 282 46
• MDR Report Key: 6456667
• MDR Text Key: 71838200
• Report Number: 9681684-2017-00021
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCSAN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Distributor Facility Aware Date: 03/07/2017
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/04/2017
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2012
• 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): Other