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

Model Number KMCSXN-D

Device Problems Bent (1059); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The conclusions will be provided upon the manufacturers investigation completion.

Event Description

On 2016-nov-22nd arjohuntleigh has become aware of a customer complaint on maxi move passive floor lift.It was reported by the customer that the top of the lift dislodged while trying to lift a resident.No one was injured or hurt.The service technician found that the spreader bar was not locking into the lifting arm assembly (t-bar).The bent t-bar was replaced.

Manufacturer Narrative

An investigation was carried out into this complaint.As it was initially reported, the customer advised that top of the maxi move passive floor lift dislodged while trying to lift a resident- the claimed part was a dummy block (t-bar) allowing spreader bar (otherwise hanger bar) attachment into it.Taking into account both facts, the complaint was decided to be reportable to the competent authorities in abundance of caution as the information available at that time suggests spreader bar detachment from lifting arm while trying to lift a resident.The spreader bar (that holds the sling and patient) to the t-bar (that connects to the lifting arm of the device) attachment is called the "lock & load system" in the labeling of the device.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 of the spreader bar.Furthermore, during this manual lifting of the spreader bar, a secondary component called the retaining catch would need to be manipulated 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.The involved maxi move was inspected by arjohuntleigh representative.During the inspection, it was found that the t-bar was bent and therefore not locking the hanger bar completely.It was also confirmed with the customer that no one was injured or hurt as the device was put out of service when the was noticed.The arjohuntleigh representative replaced the faulty dummy block with a new one.Please note that the additional information provided by our representative has revealed that the device was being checked prior to use when it was noticed that the spreader bar was not locked into place.The device was removed from service afterwards.It was not being used for treatment or diagnosis of the patient.No dislodgement of the spreader bar, neither t-bar itself occurred at all.Bearing in mind the gathered data, we do not believe this kind of complaints to be reportable to the competent authorities as no serious injury occurred and if the event were to reoccur, it would not be likely to cause or contribute to a death or serious injury based on our findings.The general condition of the device was described as average with small scratches and signs of normal wear.It is under arjo service contract, however a date of its last maintenance/service was not provided.No complaint trend for this failure mode exists.In course of this investigation it has been tried to establish the most likely root cause of the reported failure - the bent t-bar.It is very likely that the reported failure was caused by hitting against obstacles such as wall, ceilings, doorframes or furniture as external force is needed to be applied to lead to deformation of this part.Please note that the maxi move instruction for use (rev.11 from january 2014) warns the user: "warning: before raising the mast make sure there is enough clearance above the maxi move to ensure the safety the safety of the patients and the people around, and to avoid injuries.Be very careful when lifting next to a door frame." "warning: during displacement, always make sure there is enough clearance above the maxi move to ensure the safety of the patient and people around, and to avoid injuries.Be very careful when passing through door openings." it could be stated that the most likely root cause of the claimed issue is use error - not following the guidance provided by the manufacturer in the instruction for use during maneuvering with the device.Please note also that the labeling of the device explains the way of proceeding to ensure that the spreader bar is safely connected and secured to the t-bar - "(.) hold the attachment firmly with both hands, without pushing on the locking clip thumb pads, and lift the attachment firmly.If the attachment becomes dislodged from the t-bar, do not use the maxi move.Contact your arjohuntleigh agent." looking at the event scenario, when it occurred, the device was not being used for treatment or diagnosis of the patient.The device was not directly involved with the reported incident or adverse event either.It was found failed to meet its specification as one of its part was bent and therefore not locking the hanger bar completely.Please note that taking into account the investigation's conclusions and findings, arjohuntleigh does not believe this kind of complaints to be reportable to the competent authorities as no serious injury occurred and if the event were to reoccur, it would not be likely to cause or contribute to a death or serious injury.

• 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: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6192533
• MDR Text Key: 62910584
• Report Number: 9681684-2016-00066
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service Personnel
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/18/2017,11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: KMCSXN-D
• 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: 01/18/2017
• Distributor Facility Aware Date: 11/22/2016
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/18/2017
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2014
• 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