MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. MAXI 500; NON-AC-POWERED PATIENT LIFT

Model Number KM560001

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) arjohuntleigh received customer complaint that during the resident transfer from bed with maxi 500 lift and sling, loop of sling detached from spreader bar of lift and resident slipped out of and fell to the floor.As a consequences resident sustained "c2 fracture and subarachnoid hemorrhage".It was informed that neck immobilizer was applied.Additionally, resident had plastic surgery on her ear.

Manufacturer Narrative

This report is being filed under exemption e2012068 by (b)(4).Arjohuntleigh received a customer complaint where it was indicated that during the resident's transfer process from the bed to the recliner using passive floor lift and the sling fitted with loops, the right shoulder loop of the sling detached from the maxi 500 hanger bar.The resident slid out of the sling and hit the recliner arm and then the floor with her head.She sustained a back pain, c2 fracture and ear injury required medical intervention as a consequence of the event.When reviewing similar reportable events, we have found a low number of cases with similar fault description (loop "detachment").The maxi 500 lift and the sling loop were inspected.The scratches on the lift were observed, however no malfunctions were found that could have caused or contributed to the event.It can be established that the sling and the lift, which work together as a system, were found to have not been up to the manufacturer's specification when the event took a place and were being used for patient handling.From the sequence of events, it was reported that during transfer procedure of a resident, the loop sling came loose on the right shoulder side and the resident fell.From review of the complaint it appears this does not mean the sling failed or came apart, but that the sling is indicated to have come away from the spreader bar it was attached to.Based on this reported information and our product knowledge, the possibility that a sling was not attached at all as well as possibility that the sling was properly attached within the spreader bar hooks when the resident was lifted is considered to be highly unlikely.The probable cause of the detachment of the sling is an incorrect sling installation and/or manipulation of the lift.The straps are prompt to detach during the early lifting of the patient and detach as soon as the tension is applied to the straps or during the manipulations prior the lifting.In this case, the strap incorrectly installed slipped from the latch as soon as tension was applied to the strap.Therefore, it is considered that the loop was improperly attached when the patient was lifted, and suddenly detached later on during the transfer.This appears most likely to be in line with the event description.It should be pointed out, that maxi 500 instructions for use (ifu, 001.20815.En rev.6) warns: "warning before using your maxi 500, you must read and fully understand these instructions.You must be trained on the maxi 500 and on any accessories as well as its functions and controls".Ifu provides the guidance of proper sling attachment: "connect the shoulder loops of the straps and the sling leg pieces under the thighs by lifting one leg at a time"."when all the connectors are securely attached, raise the patient from the bed." following information received it appears most likely that sling loop was improperly attached when the patient was being lifted as the caregiver did not notice the inadequate attachment during transfer, which constitutes an use error.Arjohuntleigh suggests to remind the staff involved of the device labelling, with special attention to correct lifting procedure and proper inspection of sling before transfer.This is to be communicated to the customer.To conclude, maxi 500 lift and loop sling were used for patient's care at the time of the event occurrence and only from that perspective they contributed to the alleged event.Since slipped out of sling was indicated, it can be stated that the system did not meet its performance specification.We report this event to competent authorities due to the patient outcome: serious injury.

• Brand Name: MAXI 500
• Type of Device: NON-AC-POWERED PATIENT LIFT
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X 5 Y5; CA J1X 5Y5
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62052 ; PL 62052
• MDR Report Key: 6885712
• MDR Text Key: 87199101
• Report Number: 9681684-2017-00072
• 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
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: KM560001
• 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: 10/23/2017
• Distributor Facility Aware Date: 08/24/2017
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/23/2017
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2010
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 103