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

Model Number KMCSUN

Device Problem Detachment Of Device Component (1104)

Patient Problems Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 arjo has become aware of the event involving maxi move passive floor lift and a mesh clip sling (maa4060m), which occurred at oakwood park lodge facility located in (b)(6).It was reported that during resident transfer in semi-flower position to the tub room, when the caregivers noticed that the room was already occupied by other resident, they stopped abruptly and the left leg clip detached from the hanger bar.As a result, the resident slid out the back of the sling and fell to the floor.The resident sustained a shallow 2'' cut on the back of the head and bruising to the upper back.According to arjo representative, who visited the facility the staff already occupying the tubroom stated that was not what they saw: "they would not elaborate but just said that's not the way they saw it happen.".

Manufacturer Narrative

On 2018-may-09 arjo has become aware of the event involving maxi move passive floor lift and a clip sling (maa4060m), which occurred at (b)(6) facility located in (b)(6) canada.It was reported that the resident was being transferred in semi-flower position to the tub room.When the caregivers responsible for transferring the patient entered the tub room they noticed that the room was already occupied by another resident.They abruptly stopped the transfer and then left leg sling clip detached from the hanger bar.As a result, the resident (74 years old female, weighing 61 kg) slide out from the back of the sling and fell to the floor.The resident sustained a shallow 2'' cut on the back of the head and bruising to the upper back.According to arjo representative, who visited the facility the staff that was in the tub room at the time of the event had a slightly different version of what happened than the caregivers responsible for transporting the resident: "they would not elaborate but just said that's not the way they saw it happen." administrator of the facility indicated that this was an use error and believes that the clip was not properly applied.After receiving the communication about the incident occurrence, arjo service technician was dispatched to conduct the devices inspection with regards to the alleged issue.Both the maxi move lift and the clip sling were in good working condition.All parts were intact, no mechanical faults were found.The maxi move instructions for use (ifu 001.25060.En rev.4) warns: "before using the maxi move a clinical assessment of the patient's suitability for transfer must be carried out by a qualified health professional considering that, among other things, the transfer may induce substantial pressure on the patient's body" "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" the passive clip sling instructions for use (ifu 04.Sc.00-int1_2) warns: "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during the lifting process" what is more, the sling ifu indicates the steps of proper sling attachment and lifting process: "[.] 16.Slightly lift the resident to create tension in the sling.17.Make sure that: · all clips are securely attached · all straps are straight (not twisted) · the resident lays comfortably in the sling.[.]" based on the product knowledge and a technical simulation conducted in the past, it comes forward that when the labeling is followed and the sling is placed in the correct way, there is no possibility of a patient drop or other adverse event during the transfer of the patient with the sling and lift.A 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 labeling, is locked in position with the weight of the patient.It cannot go downward as it is suspended on said clip attachment lug, and it cannot go upward because it is pulled down by the weight of the patient.Review of similar complaints, reported in the past confirmed that this failure is only possible to occur when the labeling is not followed.To conclude, the system - clip sling and lift, was used for patient's care.No defect has been found within the clip, but since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.Upon the conducted investigation and devices inspection done by the arjo representative, we were able to determine that a use error contributed to the incident occurrence- the clip was not properly applied.We report this event to competent authority based on the potential of serious injury if the incident would to reoccur.

• 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
• MDR Report Key: 7577026
• MDR Text Key: 110342151
• Report Number: 9681684-2018-00042
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: KMCSUN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/04/2018
• Distributor Facility Aware Date: 05/09/2018
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/04/2018
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 61