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  

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
• MDR Report Key: 18502211
• MDR Text Key: 332766953
• Report Number: 1419652-2024-00005
• 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: Distributor
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2024
• Distributor Facility Aware Date: 12/29/2023
• Event Location: Nursing Home
• Date Report to Manufacturer: 01/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 44 KG