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

Model Number KM560101

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 12/22/2023

Event Type  Injury  

Manufacturer Narrative

Following the information provided the the sling loops were attached correctly to the lift spreader bar and remained attached post-fall.Arjo slings with head support have two pockets at the head section, which contain plastic reinforcement pieces - stiffeners.The two plastic stiffeners are placed in the pockets of the sling to support the patient's head during the transfer.The device evaluation showed that the parts were missing.During the conversation with the customer, it was confirmed that the caregivers had not witnessed the entirety of the fall from the lift.One has indicated that at the time of the fall, she was looking away and at the wheelchair, and, the other indicated that during the fall she was looking down at the lift legs whilst she attempted to maneuver the lift.Both caregivers stataed that they were focused on getting the lift between the wheelchair wheels and were not keeping track of the resident.The passive sling loop instruction for use instructs to : ¿check that the stiffeners are completely inside the stiffener pockets if any.¿ following all the details reported, the resident fall was unwitnessed by the caregivers.Additionally, the missing stiffeners in the sling head section could influence the resident¿s stability in the sling.To sum up, the arjo passive floor lift and arjo passive loop sling were used as a system for a patient transfer when the patient fell out of the device and sustained a serious injury and from that perspective the system failed.The complaint was decided to be reportable due to allegation that the patient slip out of the sling.

Event Description

The arjo was informed about an event involving a maxi 500 passive floor lift and sling ( model number mlaas2000-m, serial number (b)(6).Following the information provided during the resident's transfer from a bed to a chair the resident fell backwards out from the device and as a consequence of the event sustained a laceration to the forehead, requiring 10 staples and bruising on the left eye and behind left ear.After the event, the lift and sling were tested by an arjo representative.The lift visual inspection revealed minor scratches to the base of the lift.The functional inspection did not reveal any malfunction.The sling visual inspection revealed missing stiffeners.

• Brand Name: MAXI 500
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18502210
• MDR Text Key: 332766967
• Report Number: 9681684-2024-00003
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 05055982762366
• UDI-Public: (01)05055982762366(11)210127
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KM560101
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 44 KG