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 Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

Arjo received an information indicating that during use of the arjo maxi move passive floor lift with a patient, the spreader bar (part on which patient and the sling are attached on) disconnected from the lifting arm.The caregivers were able to prevent the hard fall of the patient.No treatment nor hospitalization was required.

Manufacturer Narrative

On 2018-06-06 it was reported to arjo representative that during resident's transfer to the bed, the spreader bar detached from the lifting arm.While the resident was lowered over the bed, the spreader bar started to fall with the resident.The caregivers were able to catch the resident to prevent hard fall.There was no injury reported.After the event, the device was tested by arjo service technician.The device evaluation showed that the spreader bar locking clip was broken.All other functions were working properly, no malfunction was found within device's functions.The service technician could not recreate the initially reported event and confirm customer's allegation - fall of the spreader bar from the device without any impact.However, he was able to re-create situation reported by the customer in the different manner: the lift was lowered onto the obstruction and the spreader bar detached from the lifting arm.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.Moreover the device has a design that clearly shows to the user when the spreader is and when it is not correctly engaged.A smiley face appears when the spreader bar is locked in place correctly.The devices are equipped with instruction for use (ifu) which provide information how to correctly use the device.The ifu for maxi move (001.25060.En rev.5) contains warnings: 'warning: if any doubt about the correct functioning of the maxi move, do not use it and contact the arjohuntleigh service department"."caution: before and during operation of the powered dps spreader bar, ensure all obstructions are clear of the spreader bar, support frame and jib." "always ensure the spreader bar is securely connected to the jib before starting to lift." the device has a design that clearly shows to the user when the spreader is and when it is not correctly engaged.A smiley face appears when the spreader bar is locked in place correctly.However, it was found under internal simulation that, under special conditions, if the locking mechanism is broken, 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) transfer is at the final phase, 2) the dps is unloaded, 3) the locking mechanism is broken, 4) the spreader bar is lowered onto an object (such as wheelchair arm), 5) the dps topples over.Following a description of the reported event, it corresponds to above described sequence of events.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 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.The photographic evidence provided by the service technician showed that despite broken part of the locking clip, it was able to attach the spreader bar correctly to the device.The information provided by service technician confirms that, if the locking clip or any part which locks the hangar bar on the lift became broken, the spreader bar might detach if caregiver lowered the device and it hits an obstruction.To conclude, arjo maxi move passive lift played a role in the complaint issue when the event occurred as it was used for resident's transfer.Although device did not meet its performance specification because the spreader bar's locking clip was broken, these malfunction did not affect directly the spreader bar failure.We report this event to competent authorities due to fact that patient fall from the device.

• Brand Name: MAXI MOVE
• 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: 7637058
• MDR Text Key: 112296236
• Report Number: 9681684-2018-00052
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCLUN
• 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: 07/13/2018
• Distributor Facility Aware Date: 06/05/2018
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/13/2018
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2011
• 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): Other
• Patient Age: 85 YR
• Patient Weight: 84