MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI 500; FSA

Model Number KM560101

Device Problems Use of Device Problem (1670); Device Tipped Over (2589); Device Handling Problem (3265)

Patient Problems Contusion (1787); No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.After review of the reportable complaints for 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 amount of sold devices and with comparison to the daily use of them, the trend observed for complaints with this failure mode is considered to be low.It was reported to arjohuntleigh that when two caregivers were transferring resident from bed to broda chair with the maxi 500 lift, the right leg of the device raised approximately 4 inches while the maxi 500 leaned to the left - its left leg made contact with the broda chair frame.The lift did not tip over completely.The resident had to be raised high in order to avoid contact with the chair arm rest.One of the caregivers experienced arm strain (found not serious injury by qualified clinical expert) when trying to prevent the lift from falling over.According to the provided information, no treatment, neither hospitalization was required.No injuries to resident were reported.The lift was in good working order as inspected by the sales and service unit representative, no malfunction of the device was found - it met its specification.Taking into account this fact, any malfunction of the lift can be excluded as a contributing factor to the event.Its general condition was described as good.Please note that our (arjohuntleigh) lift devices fulfill the iso 10535 requirements of being stable with the safe working load weight in the most adverse position.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 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: "always use the handles to manoeuvre the lift." (p.8); "warning: never attempt to manoeuvre the lift by pulling on mast, boom, actuator or patient.Doing so could cause incidents resulting in injuries." (p.8); "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." (p.8); "do not push the lift at a speed which exceeds a slow walking pace (3 km/hour or 0.8 meter/second)."(p.8); "before raising the patient, always make sure the sling is not caught on any obstructions (for instance, the wheelchair, brakes or armrest).Sling catching in such obstructions could result in patient fall." (p.14); it appears more likely that the improper use of the device (user error) contributed to the incident.Based on the event description, review of previous related complaint investigations and the technician conclusions, it seems the maxi 500 was not correctly positioned above the broda chair.It appears likely that the person in the sling was vehemently pulled into the desired position and the lift tipped in the direction that was pulled (left side).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 device was being used with patient handling and was working to specifications, when due to a use error it tipped and thereby contributed to the described event and the resulting risk situation.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.

Event Description

On 2016-oct-5th, arjohuntleigh has become aware of a customer complaint - as reported, two caregivers were transferring resident from bed to broda chair with the maxi 500 lift.During the transfer, the right leg of the device raised approximately 4'' while the maxi 500 leaned to the left - its left leg made contact with the broda chair frame.The lift did not tip over completely.One of the caregivers experienced arm strain when trying to prevent the lift from falling over.According to the provided information, no treatment, neither hospitalization was required.No injuries to resident were reported.

• Brand Name: MAXI 500
• Type of Device: FSA
• 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: 6065614
• MDR Text Key: 58939380
• Report Number: 9681684-2016-00051
• 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: Inspection
• Type of Report: Initial
• Report Date: 10/29/2016,10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nursing Assistant
• Device Model Number: KM560101
• 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: 10/29/2016
• Distributor Facility Aware Date: 10/05/2016
• Device Age: 1 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/29/2016
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2015
• 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: 66 YR