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

Model Number KM560101

Device Problem Detachment Of Device Component (1104)

Patient Problem Head Injury (1879)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 arjohuntleigh has been informed by facility (fox developmental center) that during the resident transfer from wheelchair to bed with maxi 500 lift and sling, one of sling loop detached from spreader bar of lift.As a consequences the resident sustained a small cut on the back of head.The patient was given first aid bandage and ointment at the facility.

Manufacturer Narrative

This report is being filed under exemption e2012068 (b)(4).On 05th december 2017 arjohuntleigh has been notified by facility that during the transfer of resident from wheelchair to bed using arjohuntleigh system: maxi 500 lift and loop sling, the loop of sling came away from the spreader bar it was attached to.The resident sustained a small cut on back of the head as a consequences of the fall.The patient was given first aid: bandage and ointment at the facility.When reviewing reportable complaints on maxi 500 registered during last 5 year with similar fault description (loop detachment), we have found a limited number of reportable complaints.The customer was visited by arjohuntleigh representative to perform the inspection of the involved sling and lift device.The sling was found with no readable label and without stiffeners.Except for the worn braked castors and handset, the lift operated correctly.No technical deviation was identified within lift as well as sling, which could have contributed to the event.Passive loop sling is a product intended for assisted transfer of residents with limited ability to move.Passive loop sling should be used together with arjohuntleigh lift devices.Product's instruction for use (ifu) is provided with each device.Before every use, ifu describes the methods of use.The equipment shall be assessed against, inter alia, frying, tears, unreadable label.The loop sling instructions for use (04.Sl.00 int1 3) warns: "warning: to avoid injury, always make sure to inspect the equipment prior to use." "if any part is missing or damaged do not use the sling".Based on this reported information and our product knowledge, the 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.There are following incorrect installations that could possibly results in the straps detaching from the lift: - strap around the safety latch, - strap on the top of the hook, strap on the top of the hook, inside hook.- therefore, it is considered that the loop was improperly attached when the patient was lifted, and suddenly detached later on during the transfer.It should be pointed out, that maxi 500 instructions for use (ifu, 001.20815.En rev.8) 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: - "position the spreader bar close enough to be able to connect the loops located on the straps of the sling" - "ensure that all loops are securely connected, then raise the patient using the hand control." ifu provides also pictographic guidance of proper sling attachment.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 falling through 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 potential as falling to the floor may result in serious injury if it would reoccur.

• 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
• MDR Report Key: 7137239
• MDR Text Key: 96047109
• Report Number: 9681684-2017-00105
• 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: 01/19/2018

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: KM560101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2018
• Distributor Facility Aware Date: 12/05/2017
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/19/2018
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other