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

Model Number KMCSUN

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the manufacturer's investigation.

Event Description

On (b)(6) 2017 arjohuntleigh received information about an event which occurred with the involvement of maxi move passive floor lift and clip sling.It was reported that during patient transfer from wheelchair to bed, one of the sling clips detached from lift's hanger bar and the patient fell.The patient sustained a fracture to ribs and vertebrae.

Manufacturer Narrative

On 14 feb 2018, it was clarified that the involved patient was hospitalized due to fractures and later returned to the nursing home.A few days after she returned to the nursing home, the patient passed away.At this time, it was not confirmed if the resident death was directly related to the reported fractures.Additional information will be provided upon conclusions of the manufacturer's investigation.

Manufacturer Narrative

On 27 dec 2017, arjohuntleigh received information about an event which occurred with the involvement of maxi move passive floor lift and clip sling.It was reported that during patient transfer from a bed to a wheelchair, one of the sling clips detached from lift's spreader bar and the patient fell.As a consequence, an (b)(6) female sustained fractures to her ribs and vertebrae and required a medical intervention.On (b)(6) 2018, it was clarified that the involved patient was hospitalized due to fractures and later returned to the nursing home.A few days after she returned to the nursing home, the patient passed away.The initial reporter did not provide any additional details about the prior condition of the patient, or the relationship between the previous hospitalization and date of death.There was no failure with the sling, and no malfunction within the involved lift found upon the arjohuntleigh inspection, that could have caused or contributed to the resident's fall.The passive clip sling is a product intended for assisted transfers of residents with limited ability to move.The product's instruction for use (ifu) is provided with each device and describes the methods of use.Ifu (04.Sc.00-int1 rev.2) 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 the lifting process.According to the instruction for use for maxi move lift (ifu 001.25060.En rev3): "always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient's weight is gradually taken up." based on the product knowledge and a simulation, when the labeling is followed and the sling is placed in the correct way and the instructions of using the system are followed, it is very unlikely a patient drop or other adverse event during the transfer of the patient with the sling and lift will occur.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 stated in the labeling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on the clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.When reviewing reportable complaints for maxi move registered during last 5 years with similar fault description (clip detachment), we have found a limited number of reportable complaints.Review of similar complaints reported in the past confirmed that this failure is only possible to occur when the labeling was 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 authority as the adverse event occurred.

• Brand Name: MAXI MOVE
• 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: 7211649
• MDR Text Key: 97945605
• Report Number: 9681684-2018-00006
• 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,Followup
• Report Date: 02/28/2018

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: Health Professional
• Device Model Number: KMCSUN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Distributor Facility Aware Date: 12/27/2017
• Device Age: 8 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 02/14/2018; 02/14/2018
• Supplement Dates FDA Received: 02/16/2018; 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 84 YR
• Patient Weight: 59