MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI SKY 600; LIFT, PATIENT, NON-AC-POWERED

Model Number LD10209

Device Problem Detachment Of Device Component (1104)

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

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On (b)(6) 2018 arjo received a service request with indication that the sling clip detached from the maxi sky 600 ceiling lift's spreader bar.The lift was inspected by arjo representative.No additional information was released at that time.On 2018-03-19 arjo representative visited the customer.Following information was received: the clip detachment failure occurred during resident transfer from a bed to chair.According to the information provided from the customer facility staff, the sling was applied for the resident (female, (b)(6)) when she was lying in bed, the clip attachments were checked for their proper location.While the caregivers raised and moved resident towards the chair, the leg clip detached and the resident's leg came loose (according to caregiver statement: "shoe hit the floor").The clip detachment issue was noticed by the caregiver, who pushed the resident back over the bed.Fortunately, no injury to the resident or caregiver occurred.It was noted that the resident has dementia related issues and does move, kick, is combative from time to time when being lifted.Caregivers were uncertain, could not recall if resident was kicking or being combative during this event.The inspection of the involved ceiling lift was performed by an arjohuntleigh representative.The lift was found to be in good working condition.There were no claims regarding the sling (maa4000m-s, manufactured on april 2017) reported.When reviewing similar reportable events, we have found a number of cases with similar fault description (clip detachment).A sling clip, once correctly attached and monitored to stay in place by caregivers 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.It cannot go inward because it is stopped by the metal frame of the spreader bar.It cannot go outward because it is stopped by the metal end stop of the clip attachment lug.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.Previous simulations have established this to be at minimum over 13% of the body weight of the patient.During the clip detachment the person is likely to fall away from the sling, toward the corner where the clip is not in place.Following all details reported the patient was lifted from the bed, therefore from the horizontal position.From simulations, we know that a person can be lifted from a horizontal position with one of the leg clips not in place.However, typically when the patient is at the end of that transfer, put into a more upright, seated position before lowering to a wheelchair, the weight shifts towards the missing clip strap and the person falls out.Following the above scenario, it would appear possible that one of the clips was not in place at the start of the lifting procedure (it could have become wiggled off before being lifted from bed) and when the weight would shift as the patient was put into a more upright, vertical position the person would slide out.It is also possible that the clip went upward when it was not under tension and remained attached, but the attachment was unstable.An unstable position of clip could led to clip detachment on the beginning of lifting (just when tension was applied) or in the middle of transfer (when repositioning, transferring with sudden jerk or patient movement).The caregivers are obligated to check the clip attachment before transfer, as well as check that all clips continue to be in place during lifting process.It is a double check that the clips were put on, but also a way of monitoring that the clips were somehow not pushed off while they were not under tension, before the weight of the patient gradually was put on them during lifting.The maxi sky 600 instructions for use (ifu 001.14150.33 rev.15) warns: "always confirm that the sling remain attached as the weight of the patient is taken up.A wrongly fixed attachment could detach resulting in patient fall." the passive clip sling ifu (04.Sc.00 rev.2) also warns: "to avoid the resident from falling, make sure that the sling attachments are attached securely before and during lifting process." what is more, the sling ifu indicates the steps of proper sling attachment and lifting process: "[.] 18.Slightly lift the resident to create tension in the sling.19.Make sure that: all clips are securely attached.All straps are straight (not twisted).The resident lays comfortably in the sling.[.]." it was indicated that the resident was combative and prone to kicking from time to time, when being lifted.In this case the caregivers shall cross the leg clips, as it is stated in the lift ifu: "if the resident is prone to kicking off the leg clip, the crossed attachment of the leg clips shall be applied, which will prohibit the clip from being kicked off." finally, the labelling for the lift device and sling indicate the system should be used by trained personnel that are aware of the ifu contents.It is worth noting that no malfunction with the sling, neither lift that could have caused or contributed to the clip detachment was reported.Based on the product knowledge and simulations, it comes forward that when the labeling is followed and the sling is placed in the correct way and the instructions of using the system are followed, there is no possibility of a patient drop or other adverse event during the transfer 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 ceiling lift was used for patient's care and in that way contributed to the alleged event.No defect has been found within the sling and lift, but since the sling clip detached from the spreader bar, it can be stated that the system did not meet its performance specification.We report this event to competent authorities based on the potential for serious injury if the incident would to recur: clip sling detachment upon the transfer.

Event Description

On (b)(6) 2018 arjo received a service request with indication that the sling clip detached from the maxi sky 600 ceiling lift's spreader bar.The lift was inspected by arjo representative.No additional information was released at that time.On 2018-03-19 arjo representative visited the customer.Following information was received: the clip detachment failure occurred during resident transfer from a bed to chair.According to the information provided from the customer facility staff, the sling was applied for the resident (female, (b)(6)) when she was lying in bed, the clip attachments were checked for their proper location.While the caregivers raised and moved resident towards the chair , the leg clip detached and the resident's leg came loose(according to caregiver statement: "shoe hit the floor").The clip detachment issue was noticed by the caregiver, who pushed the resident back over the bed.Fortunately, no injury to the resident or caregiver occurred.It was noted that the resident has dementia related issues and does move, kick, is combative from time to time when being lifted.Caregivers were uncertain, could not recall if resident was kicking or being combative during this event.The inspection of the involved ceiling lift was performed by an arjohuntleigh representative.The lift was found to be in good working condition.There were no claims regarding the sling (maa4000m-s, manufactured on april 2017) reported.

Manufacturer Narrative

In the report submitted on 12 apr 2018, the incorrect awareness date (14 mar 2018) has been provided.Arjo received a service request with indication that the sling clip detached from the maxi sky 600 ceiling lift's spreader bar on (b)(6) 2018, therefore the section date user facility or importer became aware of event and date received by manufacturer were corrected.

• Brand Name: MAXI SKY 600
• 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: 7424789
• MDR Text Key: 105885033
• Report Number: 9681684-2018-00032
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: LD10209
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Distributor Facility Aware Date: 03/15/2018
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/18/2018
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/15/2018
• Supplement Dates FDA Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 36