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

Model Number KMCLUN

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided following the conclusion of the investigation.

Event Description

During attempt to patient transfer (when the patient was not yet in a spreader bar), the spreader bar detached.The patient remained in a seated position.There was no injury in result of the reported event.

Manufacturer Narrative

On 2017-nov-02 arjohuntleigh has become aware of an event which occurred with the involvement of maxi move passive floor in (b)(6) customer facility located in (b)(6), usa.It was reported that at the initial stage of patient transfer, when the patient was still sitting, the spreader bar came off from the t-bar.No injury sustained.On the same day, the involved device was inspected by arjohuntleigh representative.The arjohuntleigh floor lift was found in a good technical condition with scratches on chassis, legs and jib cover.The left locking pin was found to be missing from the spreader bar.When reviewing similar reportable events, we have found a number of cases with similar fault description (spreader bar detachment during use with the patient).Based on product knowledge, description of the event and review of similar situations that took place in the past, the spreader bar detachment failure can occur only when a user did not follow correct transfer procedure as presented in the device labeling.The spreader bar to t-bar attachment is called the lock & load system in the labeling of the maxi move lift.The lock & load system is designed so that, when the spreader bar is connected to the t-bar, only a manual lifting of the spreader bar would allow separation (detachment) of the spreader bar.Furthermore, during this manual lifting of the spreader bar, a secondary component called the retaining catch (part of locking clip) would need to be pushed in order to allow for the separation.This retaining catch is designed to prevent an inadvertent separation of the spreader bar due to an unintended upward force applied to the spreader bar.The guiding (locating) pins are parts of the spreader bar, designed to guide the spreader bar onto the t-bar.If they are missing, bent or damaged the shape of the spreader bar will still encapsulate the t-bar like hand-in-fist.It is possible the pin breaks off when treated roughly: having the spreader bar collide with objects.Please note that on-label use of the device does not allow for such collisions.The overall condition of the involved lift confirms that the lift was used in an abusive way.The maxi move instruction for use (ifu) is provided with each device.Ifu (001.25060 rev.5, april 2011) informs how to install spreader bar in the safe and correct way: "to install an attachment: select the attachment required and - while carefully handling it, with the locking clip thumb pads facing you - allow the recess in the attachment to fit around the t-bar shaft.Ensure the attachment drops down over the t-bar and that the locking clip engages fully." the ifu also warns: "always check that the attachment is locked in place by: 1) verifying the markings on the attachment that show that there is a proper alignment, and 2) verifying that the locking clip is fully engaged, thus ensuring that the attachment is securely fastened." "do not lower the attachment onto rigid surfaces (e.G.Bed, floor, wheelchair armrests, etc., to avoid the possibility of the attachment becoming dislodged from the t-bar.A dislodged attachment may later detach completely from the unit, causing the patient to fall." the maxi move ifu indicates how to test the attachment: "to ensure that the attachment is safely connected and secured to the t-bar, hold the attachment firmly with both hands and, without pushing on the locking clip thumb pads, lift the attachment upwards firmly.If the attachment becomes dislodged from t-bar, do not use the maxi move.Contact your local arjohuntleigh representative." test was performed to compare on-label to off-label use and the impact of certain malfunctions (including missing guiding pins) to the safe functioning of the maxi move lift.It was concluded that missing guiding pins by themselves are very unlikely to cause an adverse outcome.The device has a design that clearly shows to the user when the spreader is and when it is not correctly engaged.However, it was found under internal simulation that, under special conditions, if one guiding pin is missing, the smiley face is present, but the locking clip could potentially be ineffective if a certain sequence of events takes place.This involves a situation where: 1) in beginning or end of transfer onto a solid object, 2) the dps is unloaded, 3) one guiding pin is missing, 4) the spreader bar is lowered onto an object (such as wheelchair arm), 5) the dps topples over this failure is easy to be recognized by the user if the lift is visually checked as required by the instructions for use (daily check to inspect external fittings is indicated to be mandatory in the care section of the ifu).Also, as per ifu, the user is obliged to check that the spreader bar is locked in place by trying to lift it without unlocking the locking mechanism.When the locking mechanism is broken, when the lock does not catch for other reasons or when the spreader bar is balanced on top of the t-bar -possibly in combination with broken pins or other malfunctions and use errors- and the spreader bar is lowered onto an object (e.G.Bed, chair) the spreader bar will only topple over when it is pushed up and not held into position by the weight of the person in transfer, and not held back by an attached sling.In that case the spreader bar will topple away from the face of the person.Patient or user is not in any immediate danger and is not exposed to a risk to health, as long as the device is used according to labeling and in particular the spreader bar is correctly attached and checked to be locked into place before each transfer.To conclude, arjohuntleigh maxi move passive lift played a role in the complaint issue when the event occurred as it was used for resident's transfer.The spreader bar detached during initiation of resident's transfer.Although device did not meet its performance specification because the spreader bar's locking pin was missing, this malfunction did not affect directly the spreader bar detachment.We report this event to competent authorities due to a malfunction that occurred (spreader bar detachment during use with a patient).

• Brand Name: MAXI MOVE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• MDR Report Key: 7107444
• MDR Text Key: 95768382
• Report Number: 9681684-2017-00098
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KMCLUN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Distributor Facility Aware Date: 11/02/2017
• Device Age: 5 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/11/2018
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other