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

Model Number KMCLXN

Device Problems Device Tipped Over (2589); Device Handling Problem (3265)

Patient Problems Laceration(s) (1946); Skin Discoloration (2074)

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

An investigation was carried out into this complaint.The overall occurrence rate for the incidents where tipping of the maxi move was reported is currently slightly decreasing.The occurrence rate observed for complaints with the similar failure mode in last 5 years is considered to be low and stable.It was reported to arjohuntleigh that during resident transfer from bed, the maxi move lift fell over.Unfortunately, the facility has not revealed any more specific details of this incident.As a consequence of the device tipping, the resident has sustained a laceration required 7 sutures (stitches) and discoloration surrounding his eye.No injuries to the caregivers have been reported.The provided information suggests that the maxi move lift was involved with reportable incident - tipping of the device resulting in serious injury sustained.Based on previous investigations, the following factors are considered to be the possible causes for lift tipping: applying the chassis brakes while attempting to move the device, using other than maneuvering handle parts of the device to move it, for example the mast, the jib, the spreader bar or the patient, pushing the device directly on the obstructions on the floor, pushing or pulling the device sideways instead of the front direction, malfunctions of the lift or the sling.During inspection of the involved device, it has come forward no malfunction that could have caused or contributed to its tipping was found.All functions of the lift worked according to its specification except for broken control membrane pad.Please note also that our lift devices fulfill the iso 10535 requirements of being stable with the safe working load weight in the most adverse position.As required per iso 10535 a stability test was performed during design phase for maxi move device that proves that even on a tilting slope, when lifting 1.25x the safe working load, and in the most adverse position, the device does not become unstable.The factors as the stability inherent to the design of the device and the stability inherent to the condition of the device at the time of use will not be considered as contributing factors to the event.The maxi move instruction for use (001.25060 rev.4, april 2010) warns and informs the user: "maxi move must always be handled by a trained caregiver and in accordance with the instructions outlined in these operating and product care instructions"."whenever possible, always approach the patient from the front." "when opening or closing the legs on a powered chassis, care must be taken not to allow anything to stand in the way of the chassis' moving legs.For example, pay special attention when the legs are operated around chair or in doorways"."caution: the chassis rear castors have brakes which can be foot-operated when required.Do not apply the chassis brakes at this stage, as the position of the patient will adjust to the center of gravity of the lift while the patient is being raised." warning: do not attempt to maneuver the lift by pulling or pushing on the mast, the jib, the spreader bar or the patient as this can cause the lift to topple over."before lifting a person from a bed, ensure there is sufficient clearance underneath the bed to accommodate the maxi move chassis legs." "using the adjustable width chassis, it is possible to make adjustments to the chassis leg width to assist with maneuverability around obstructions, such as bed legs or castors." the cited extract from the instruction for use ensures that usage of the maxi move lift in accordance to the guidelines provided by the manufacturer will not cause or contribute to its tipping.It can be pointed out that, according to our best knowledge at this time, the most likely root cause of the reported tipping of the device problem is related to the customer misuse - not following the instruction for use.No fault was found with the involved device that caused or contributed to this event.These indications lead to the conclusion that the incident was caused most likely due to user error (lack of awareness of the ifu contents).Looking at the incident scenario it has been established that maxi move passive floor lift was being used for patient handling at the time of the event and in that way contributed to the adverse event - device tipping resulting in laceration to the resident as an outcome.There was no device deficiency found that could have caused or contributed to its tipping and from that perspective the device was up to specification at the time of the incident.

Event Description

It was reported that during resident transfer from bed, the maxi move passive floor lift fell over.The more specific details of this incident have not been revealed by the facility.As a consequence of the device tipping, the resident, has sustained a laceration required 7 sutures (stitches) and discoloration surrounding his eye.No injuries to the caregivers have been reported.

Manufacturer Narrative

(b)(4).

Event Description

• Brand Name: MAXI MOVE
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec ; CA
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 6098396
• MDR Text Key: 59727043
• Report Number: 9681684-2016-00061
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Occupational Therapist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016,10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KMCLXN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2016
• Distributor Facility Aware Date: 10/19/2016
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/14/2016
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2010
• 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 Age: 51 YR