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

Model Number KMCSUN

Device Problems Device Damaged Prior to Use (2284); Unintended Movement (3026)

Patient Problems Contusion (1787); Pain (1994)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During putting resident back to bed from his reclining wheelchair using the maxi move lift, the lift started to come down on its own but very slowly.As a result of this movement, a hanger bar came down onto resident's abdomen.The assisting staff (2 aides) disconnected the leg clips from the hanger bar so they could reposition the resident, but they ended up positioning themselves under the resident, bearing his full weight on their knees to keep him from falling to the floor.After that, the two other nurses on duty assisted to transfer resident back into his chair.No injuries to resident reported.Both involved aides sustained injuries: the first one had painful rib, received muscle relaxant medication; the other one required a right leg stabilizer from her ankle to her groin.

Manufacturer Narrative

The final report will be provided upon investigation conclusions.

Event Description

From the information collected to date, it can be assumed that usage of the heavily damaged device (two important components supporting stable position of mast actuator were missing) contributed to the event.Further data are needed to determine whether it was possibility that any earlier failure of the device could have contributed to the mentioned damage or not.Additional information will be provided following the conclusions of the investigation.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for maxi move we have found a very low number of similar events.No trend for them exists.With the amount of sold devices and comparison to daily use of a device, we find occurrence rate since 2011 to be very low.It was reported that two caregivers were transferring a resident (male) back to bed from his reclining wheelchair using the maxi move passive floor lift when that device started to lower its spreader bar on its own accord but very slowly.At that time, the resident complained that the spreader bar was crushing his abdomen.The aides detached the two leg clip attachments from the spreader bar to reposition him and stop the bar from pushing on his abdomen and thus ended up bearing the resident's weight on their knees until help arrived to prevent him from falling to the floor.The aides screamed for help and two nurses on shift assisted them to transfer the resident back into his chair.No injuries have been sustained by the resident in fact.One of the caregivers complained about painful rib and received muscle relaxant medication.The other caregiver complained about painful knee and shoulder.She was sent to local hospital and a right leg stabilizer was applied from her ankle to her groin - it was considered to be a medical intervention to prevent harm.Taking into account these allegations, the maxi move was directly involved with adverse event during that situation.As per service technician inspection of the involved device, the lift was inoperable - it did not meet its specification.It was in very bad condition - mast top cover was found completely detached with emergency lowering lever intact to it (both parts were missing from device).The emergency lowering locking pin was missing as well and the wire harness was hanging out of the top of the mast.It was stated also that it looked like the device was damaged from hitting against door frames or ceilings before the incident and it was not taken out of usage afterwards.Furthermore, a hex interface emergency lowering was broken - this could lead to dis-adjustment between emergency lowering and mast actuator - as a result of it, unintended lowering of the device with a load on it.The received information and provided photos showed that emergency lowering lever has been broken.The cause of this failure is most likely to be related to user error: - abusive use of the device - the device was found in very bad condition: the mast top cover was completely detached with emergency lowering lever intact to it; the emergency lowering locking pin was missing from the mast actuator and the wire harness was hanging out of the top of the mast."it looks like customer pushed lift into door jamb many times" as per the service technician.- the broken hex interface can only happen if the red emergency lowering lever is lifted.If the arm is lifted, there should not be any force on the hex interface.- the emergency lowering lever was lifted and the emergency pin was removed.After the lever was lowered back and the lift was still used - instead of the metal pin blocking the rotation, it was hex interface that was under stress.When the hex broke, a small drop occurred due to the sudden rotation of the top of the actuator - uncommanded lowering.The maxi move instruction for use (rev.5 april 2011) informs also about necessary checks (preventive maintenance) that are essential to preserve device's safety and performance.'care of your maxi move' section informs to: - "check that all external fittings are secure and that all screws and nuts are tight." - daily check (p.38) - "general lift condition: perform a general visual inspection of all external parts, and test all functions for correct operation, to ensure that no damage has occurred during use." - weekly check (p.39) if any parts would have found to be damaged, a device should be taken out of service and should not be used with patients.To minimize the allegations, it appears relevant to point out that as per the standard for patient lifts (iso 10535) the design of the maxi move lift device is such that there is a power cut when the device's spreader bar is lowered onto an obstruction, and the pressure by the device is not higher than the weight of the spreader bar part.This is the designed-in prevention against crushing - and even with the poor state of the device there does not appear to be an indication this prevention did not work.From above evaluation and received information we can state, that the most likely cause of this problem is user error based on our best knowledge.If maxi move's recommendation from instruction for use had been followed, there would have been no patient or caregiver at risk.The device was not up to its specification, it was used for patient handling and due to its poor condition and likely due to use error contributed to the outcome of the event.

• Brand Name: MAXI MOVE
• 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: 5935290
• MDR Text Key: 54140149
• Report Number: 9681684-2016-00036
• 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: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2016,08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2016
• Distributor Facility Aware Date: 08/18/2016
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/09/2016
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2011
• 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): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 98