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

Model Number KM560001

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.After review of the reportable complaints on maxi 500 and maxi 500 / medi-lifter 4 brand names registered within last 5 years, a limited number of similar cases (tipping of the lift) were found.With the number of sold devices and in comparison to the daily use of them, the occurrence rate observed for complaints with this failure mode is considered to be low and stable.As reported, the resident ((b)(6) years old female weighting (b)(6)) was being transferred from bed to wheelchair with the assistance of 2 caregivers.During lowering of the resident onto the wheelchair, the lift tilted to the left side.The device did not fall over completely.No injury to resident, neither caregivers occurred.The lift was inspected by arjohuntleigh representative after the incident.It was found in general good condition.There was no malfunction within the device detected.The involved sling was not an arjohuntleigh one, nevertheless no malfunction of this item was noted.Please note that our lift devices fulfill the iso 10535 requirements of being stable with the safe working load weight in the most adverse position.The factors such 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 either.As required per iso 10535 a stability test has been performed that proves that even on a tilting slope, when lifting 1.25x the safe working load, and in the most adverse position, the maxi 500 does not become unstable.The product instructions for use (ifu) as supplied with each lift includes important information concerning proper and safe use of the lift.The maxi 500 ifu (001.20815.En rev.12) contains the crucial information: "always use the handles to maneuver the lift.Close the legs and move the lift in the direction of travel (.).If necessary, initiate the movement by pushing on the back of the base with your foot.Do not push on the legs." (p.12) "warning: never attempt to maneuver the lift by pulling on the mast, boom, actuator or patient.Doing so could cause incidents resulting in injuries." "never attempt to push or pull a loaded lift over a floor obstruction which the castors are unable to ride over easily, including steps, door thresholds or moving sidewalk.Do not push the lift at a speed which exceeds a slow walking pace (3 km/hour or 0.8 meter/second)." based on the event description and review of previous complaint investigations, it seems that the maxi 500 was not correctly positioned above the wheelchair (lift legs were in open position with one blocked by the wheelchair).It is likely that the person in the sling was vehemently pulled into the desired position and the lift tipped in the direction that was pulled.As a result of that action the resident's center of the gravity changed on the lift.In the labelling of the device there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling: "the maxi 500 must always be handled by a trained caregiver, as per instructions herein, who shall attend to the patient during lift operation." in our opinion if the corresponding maxi 500 instruction for use provided by the manufacturer had been followed, risk of any incident related to usage of the device could have been avoided.To sum up, the device was being used at the time of the event for patient handling and played a role in a reportable incident due to a use error - causing the device to not perform as intended.The device was up to the manufacturer specification at the time of the incident.This complaint was decided to be reportable in abundance of caution as there is a potential that similar sequence of actions taken by the caregivers can result in serious injury.

Event Description

As reported, the resident ((b)(6) years old female weighting (b)(6)) was being transferred from bed to wheelchair with the assistance of 2 caregivers.During lowering of the resident onto the wheelchair, the lift (maxi 500) tilted to the left side.The device did not fall over completely.No injury to resident, neither caregivers occurred.

• Brand Name: MAXI 500
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052
• MDR Report Key: 6928008
• MDR Text Key: 89946664
• Report Number: 9681684-2017-00080
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KM560001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Distributor Facility Aware Date: 09/11/2017
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/09/2017
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2013
• 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
• Patient Age: 65 YR
• Patient Weight: 112