MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI 500; NON-AC-POWERED PATIENT LIFT

Model Number KM560081

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Hip Fracture (2349)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).On (b)(6) 2017 arjohuntleigh received a customer complaint indicating that during of the patient (female, (b)(6), suffering from advanced multiple sclerosis (ms)) transfer from wheelchair to bed with passive lift maxi 500 and sling, a left shoulder clip detached from a lift spreader bar and resident fell on the floor.It was informed by the facility, that as a consequence, the resident sustained a hip fracture, bruises on the right hand between the second and third knuckle and on the left hand.When reviewing reportable complaints on maxi 500 registered during last 5 year with similar fault description (clip detachment), we have found a limited number of reportable complaints.The lift and sling device was inspected by arjohuntleigh representative.The sling label was unreadable.However, no malfunctions regarding lift and sling were reported which could have caused or contributed to the event.Passive clip sling is a product intended for assisted transfer of residents with limited ability to move.Passive clip sling should be used together with arjohuntleigh lift devices.Product's instruction for use (ifu) is provided with each device.Before every use, ifu (04.Sc.00 int1_2) describes the methods of use.The equipment shall be assessed against, inter alia, damage clip."warning: to avoid injury, always make sure to inspect the equipment prior to use." "if any part is missing or damaged do not use the sling".Ifu provides also written and pictographic guidance regarding proper clip attachment process: "attach the clips (5 steps) 1.Place the clip on the spreader bar lug.2.Pull the strap down.3.Make sure the lug is locked at the top end of the clip.4.Make sure the strap is not squeezed in between the clip and the spreader bar.5.Make sure the straps are not twisted." the document guides, step by step, through a proper sling application.It is important to make sure that the clip sling is attached securely before and during lifting process.According to the instruction for use for maxi 500 lift: warning: to avoid the resident from falling, make sure that the sling attachments are attached securely before and during lifting process." the maxi 500 ifu (001.20815.En rev.8) indicates the steps of proper lifting process and also points out: "when using clip slings, always check that the sling attachment clips are correctly attached and remain in tension as the weight of the patient is gradually taken up." "before using your maxi 500 you must read and fully understand these instructions.You must be trained on the maxi 500 and on any accessories as well as its functions and controls." "do not attempt to maneuver the lift by pulling on the mast, boom, spreader bar, actuator or patient as this can cause the lift to topple over." based on the product knowledge and a simulation, it comes forward that when the labeling is followed and the sling is placed in the correct way and the instructions of using the system is followed, there is no possibility of a patient drop or other adverse event during the transfer of the patient with the sling and lift.A sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.Review of similar complaints, reported in the past confirmed that this failure is only possible to occur when the labeling is not followed.To conclude, the system clip sling and lift, was used for patient's care and in that way contributed to the alleged event.No defect has been found within the clip, but since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.We report this event to competent authorities as serious injury occurred.

Event Description

On (b)(6) 2017 arjohuntleigh received a customer complaint indicating that during of the patient (female, (b)(6), suffering from advanced multiple sclerosis (ms)) transfer from wheelchair to bed with passive lift maxi 500 and sling, a left shoulder clip detached from a lift spreader bar and resident fell on the floor.It was informed by the facility, that as a consequence, the resident sustained a hip fracture, bruises on the right hand between the second and third knuckle and on the left hand.

Manufacturer Narrative

The correction concerns the exemption statement.The correct exemption statement is following: this report is being filed under exemption e2012068 by the (b)(4).

• Brand Name: MAXI 500
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• MDR Report Key: 7192829
• MDR Text Key: 97327743
• Report Number: 9681684-2018-00002
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: KM560081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2018
• Distributor Facility Aware Date: 12/20/2017
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/25/2018
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 63