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

Model Number KMCLUN

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016 arjohuntleigh receiver customer complaint where it was reported that during transfer of the resident from bed to wheelchair, one of the sling's clip detached from maxi move lift and resident fell on the floor.As a consequences, resident sustained a fractures of right distal femur, right tibial and subdural hemorrhage.

Manufacturer Narrative

Report is being filed under exemption (b)(4) by the arjohuntleigh magog inc.(registration #9681684) on behalf of the importer (b)(4).An investigation was carried out into this complaint.Based on the information gathered it appears most likely that the incident occurred during the resident's transfer from bed to wheelchair, shoulder clip sling detached from the spreader bar of the maxi move lift and resident fell on the floor.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).The trend observed for reportable complaints with this failure mode is currently considered to be low and slightly decreasing.No malfunctions regarding lift as well as sling were found that could have caused or contributed to the event.It can be established that the sling and the lift were being used for patient handling but it appears it contributed to the event possibly due to a use error.Sling clip, once correctly attached and monitored to stay in place as the weight of the person in the sling is gradually taken up, as indicated to be required in the labelling, is locked in position with the weight of the patient.It is not likely to come off during on label use.Based on product knowledge and previously made simulations this then leaves open a possible sequences of events: from simulations, we know that in the situation, when the clip is not attached and under tension with the weight of the person in the sling from the start, a drop will be immediate.If the labelling is followed there can be no issue.However, it is possible for the caregivers to not have followed the labelling and not checked if the clips are correctly attached and remain in tension as the weight of the patient is gradually taken up.The user is obliged to monitor the clips becoming under tension when the weight of the patient is gradually being loaded on.There are additional possible causes that also involve use that is not following the ifu: when a transfer occurs from a bed, this means at some point there must be a repositioning from horizontal to seated position to place a person in wheelchair.If this scenario occurred in the middle of the resident's transfer this means that (a) the clip was in place and (b) it was locked in position by the weight of the person in the sling (therefore not likely to come off by itself).Also this means that the resident must be turned in the correct direction.As a result the caregiver must manipulate the spreader bar that holds the sling and is able to turn for this purpose.The intended and labelled use is that this occurs by operating and manipulating the spreader bar itself, and not the sling nor the person in the sling.If this labelling is followed there can be no issue.However, it is possible for the caregiver to not have followed the labelling and have used the person in the sling to manipulate the spreader bar.This scenario seems to be related also to this event.In this case the clip could be inadvertently pulled off by the caregiver while using the sling or the person in the sling for repositioning.The sling instruction for use (ifu) currently used 04.Sc.000 int1_2 contains crucial information: "to avoid injury to the resident, pay close attention when lowering or adjusting the spreader bar." "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process." the maxi move lift instruction for use (ifu 001.25060.En rev.4) contains the crucial information: "warning: do not attempt to move the lift by pulling or pushing on the mast, the jib, the spreader bar or the patient"."always check that all the sling attachment clips are fully in position before and during the lifting cycle, and in tension as the patient's weight is gradually taken up" consequently to the above, we come to the conclusion that the event was most likely caused by use error, based on the customer information and the simulations performed previously for previous incidents.The labelling for the lift device indicates the system should be used by trained personnel that are aware of the ifu contents.Note that the customer was visited and interviewed by a local arjohuntleigh representative.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to correct lifting procedure and check the sling before transfer.This is to be communicated to the customer.We find this complaint to be reportable to the competent authorities.

• Brand Name: MAXI MOVE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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,, TX 62-05-2 ; PL 62-052 ; 2103170412
• MDR Report Key: 6071767
• MDR Text Key: 58923092
• Report Number: 9681684-2016-00055
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/05/2017,10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: KMCLUN
• 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: 01/05/2017
• Distributor Facility Aware Date: 10/06/2016
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/05/2017
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2010
• 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): Hospitalization
• Patient Weight: 73